Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of mylife pura blood glucose strips in france the department of health (dh) today (february 22) drew the public's attention to the recall of certain lots of a blood glucose test strip in france. the affected product is mylife pura (box of 100) manufactured by bionime corporation. the test strips may give falsely high blood glucose readings.
the dh was informed by the french medical device regulatory authority, agence francaise de sécurité sanitaire des produits de santé (afssaps), about the recall. according to afssaps, the problem came to their notice when several reports of overestimation of blood glucose levels were received. further investigation revealed that the problem was due to the accidental opening of the unsealed vials of the test strips during transportation from the distributor in france to the pharmacies. as the test strips are very sensitive to air exposure, they may lose performance and give falsely high readings. the manufacturer has since then taken preventive action by starting to seal all the vials with a protective film.
a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia - indeed, such a case has been reported in france.
so far, the dh has not received any local report of adverse events arising from use of the product.
although there is currently no readily available evidence to suggest that the affected product has ever been exported to hong kong, the dh is following up with the manufacturer to verify that this is indeed the case. meanwhile, as a precautionary measure, members of the public who may have the above product in their hands are advised to stop using any vials which came unsealed and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai.
"for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman said.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning noxboxi inhaled nitric oxide delivery and monitoring device, manufactured by bedfont scientific.
the manufacturer noticed that some operators of the noxboxi nitric oxide delivery and monitoring device have been using components which have not been supplied or recommended by bedfont scientific.
the manufacturer has provided a list of possible components which are not supplied by bedfont scientific. in the field safety notice. these components included calibration gas, sample lines / disposables, manual bagging accessories and transportation accessories. according to the manufacturer, using such supplied parts may damage the device and cause injury or in some cases death to the patient or the operator.
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con455982
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 23 september 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device
medical device manufacturer, bedfont scientific, has issued a medical device safety alert concerning its noxboxi inhaled nitric oxide delivery and monitoring device [model number: noxboxi; serial numbers: ni100233, ni10036; software version 16.2, 15.3].
issue 1: ‘critical delivery fault’ alarm
the noxboxi firmware monitors the flow of gas through the device in order to ensure it doses the correct values to the patient. if this flow breaches the acceptable tolerance in the event of a component failure a ‘critical delivery fault’ alarm will sound and dosing to the patient will cease. this acceptable tolerance is measured in units of voltage (v). it has been identified that the acceptable tolerance in the firmware may be too close to the tolerance of the mass flow sensor used to monitor the gas flow. therefore it is possible that when changing doses in large increments or if the device is connected to a high frequency ventilator set to a frequency of 10hz and the mass flow sensor is at the upper or lower end of its technical tolerance, the ‘critical delivery fault’ alarm can be falsely triggered by a momentary spike in voltage. this alarm needs to be resolved manually.
issue 2: anomaly leading to device shut down during use
there is a small possibility that due to an operating system framework anomaly, the device may shut down during use, the user will be alerted by the visual led alarm band flashing.
the manufacturer is evaluating a firmware fix to eradicate the above two issues.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 10 june 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device
the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning noxboxi inhaled nitric oxide delivery and monitoring device , manufactured by bedfont scientific ltd. the affected serial numbers are identified as follows:
ni100004, ni100006, ni100009, ni100010, ni100011, ni10012, ni100013, ni100014, ni100015, ni100016, ni100017, ni100018, ni100019, ni100020, ni100022, ni100024, ni100025, ni100027, ni100028, ni100029, ni100030, ni100031, ni100032, ni100034, ni100035, ni100036, ni100037, ni100038, ni100039, ni100040, ni100042, ni100043, ni100044, ni100045, ni100046, ni100047, ni100048, ni100049, ni100050, ni100051, ni100052, ni100053, ni100054, ni100055 ni100056, ni100057, ni100058, ni100059, ni100060, ni100061, ni100062, ni100064, ni100065, ni100066, ni100067, ni100071, ni100072, ni100073, ni100074, ni100075, ni100076, ni100077, ni100079
according to the manufacturer, a fault has been identified within the noxboxi firmware, whereby after 6 days of continuous use the screen may freeze/lock and will not respond. after another unknown period of hours this may cause the system to crash and enter “safe” mode, at this point delivery of nitric oxide (no) therapy is stopped.
if the patient is dependent on inhaled nitric oxide, this failure could result in serious injury or death of the patient.
the manufacturer advises users not to use the noxboxi continuously for a period longer than 6 days until a firmware upgrade is implemented on the device.
a firmware fix has been released to prevent this fault from occurring (0.0.12.1), which users must install on their device immediately. if the device already has this firmware version installed no action is required.
for details, please visit the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con341279
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 december 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: scottcare telesentry model ts01
the health canada reported a medical device recall concerning telesentry model ts01 manufactured by scottcare corporation. certain telesentry devices contain a bad sd card. when the sd card goes bad, the telesentry device cannot read or write data to the sd card. the telesentry device then stops functioning.
for more details, please visit the following website:
http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/
rec-ret_md-im_date_jan-mar_2012-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: western / scott fetzer co. oxytote valve integrated pressure regulators
health canada posted a medical device safety alert concerning oxytote valve integrated pressure regulators (viprs) [model numbers: mnr-600, mns-603, mtr-500, mtr-700, mts-501, mts-502, mts-503], manufactured by western / scott fetzer co.
the manufacturer decided to initiate this recall based on reports of ignition events involving oxytote valve integrated pressure regulators (viprs) and the subsequent investigations into those events. based on the investigations, the manufacturer has become aware of the possibility of ignition and rupture (i.E., explosion) of the compressed gas oxygen cylinder, which can cause serious injury and/or death.
for details, please refer to the following health canada website:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43563r-eng.Php
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 february 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bio-rad ih-1000
the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning ih-1000, manufactured by bio-rad. the affected product reference number is 001000 and all software versions are affected.
in some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images.
therefore, this issue might lead to a wrong result released to the host if the 3 following conditions are met:
a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and,
this negative result is consistent with the global interpretation of the test and,
the system is configured without the second reading function activated for all tests results.
the manufacturer is providing work around instructions as an interim measure. a software update will be implemented to permanently correct the issue.
for details, please visit the following tga website:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00593-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 june 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bio-rad biotestcell i8, biotestcell i11 and biotestcell i11e
medical device manufacturer, bio-rad, has issued a field safety notice (fsn) concerning biotestcell i8 (code no. 816 020), biotestcell i11 (code no. 816 021) and biotestcell i11e (code no. 816 051). the affected lot number is 2422011-00.
due to subsequent exchange of one donor cell in the cell panel of the products mentioned above, an incorrect version of the worksheet was used for packaging. this worksheet contains incorrect information for cell i7. with this incorrect worksheet an identification of anti-jkb, -s and -s antibodies is not possible. misinterpretations do not occur. using the affected reagents as control reagent will lead to a discrepant result misleadingly indicating a problem with the tested reagent (e.G. seraclone anti-jkb, anti-s, anti-s).
the manufacturer advises users not to use worksheets included in the packages of the lots mentioned above. a fsn with corrected worksheets containing correct donor information for cell i7 was issued to alert users.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 20 jun 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bio-rad id-diacell i-ii-iii asia
medical device manufacturer, bio-rad, has issued a medical device safety alert concerning its id-diacell i-ii-iii asia. the affected products are identified as follows:-
product code: 45330
lot/serial numbers:
ihd lot n°: 45330 29 1 (expiry date: 09.10.2017) / sap lot n°: 167516291 (expiry date: 11.09.2017)
ihd lot n°: 45330 29 2 (expiry date: 23.10.2017) / sap lot n°: 168117292 (expiry date: 23.10.2017)
ifu/um reference: b004350 version 02.15
the manufacturer has been made aware that unexpected positive reactions may occur with the cell iii of the product id-diacell i-ii-iii asia, ihd lot n° 45330 29 1 and 45330 29 2
according to the manufacture’s health risk assessment, there is no patient risk because by following the good laboratory practice practices the issue (false positive reaction) will be identified during internal quality control.
the manufacturer requests customers to scrap any remaining goods of the ihd lots 45330 29 1 and 45330 29 2. the manufacturer is sending the lots 45330 30 1 respectively 45330 30 2 as a replacement in week 36.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 4 september 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bio-rad diamed q.C. system
medical device manufacturer, bio-rad, has issued a safety alert concerning its diamed q.C. system. the affected devices are identified as the following:-
material number: 45950
lot number ihd: i) 45950 46 1 and ii) 45950 47 1
lot number sap: i) 166035461 and ii) 172383471
expiry date: i) 25 sep 2017 and ii) 9 oct 2017
the manufacturer has been made aware that samples of the product diamed q.C. system, ihd lot number 45950 46 1 and 45950 47 1, show excessive hemolysis in samples 1 and 4, and weakly in sample 2.
tests have been performed internally and the manufacturer can confirm that currently a clear result is returned with manual testing and on the saxo- swing, ih-1000 with the hemolysed qc samples. with ih-500, users may observe uninterpretable results on reverse grouping. in this case, users should use another sample to perform the reverse grouping. [note: tests involving serum 1 and serum 2 are in no way affected.]
according to the manufacturer, a risk assessment has been performed and no patient risk has been identified. users may continue to use the hemolysed cells as long as they give the expected results.
the current situation has shown that the hemolysed lots will still allow the customers to perform qc testing for the following applications:
typing abo/d and phenotype rh kell
antibody screening and identification
compatibility testing
according to the local supplier, the affected products are not distributed in hong kong
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 september 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biomerieux etest colistin co256 ww
medical device manufacturer, biomerieux, has issued a field safety notice concerning its etest colistin co256 ww. the affected product reference numbers are 537300 and 537308.
based on scientific publications (including eucast warning letter on their website) on colistin gradient and disk diffusion tests, the manufacturer was alerted about a potential underestimation of the minimum inhibitory concentrations (mic) values for enterobacteriaceae and acinetobacter, the manufacturer initiated a complaint investigation to confirm product performance and determine root cause. while the internal and external investigations are still ongoing, to date and based on data available, the following have been identified:
the etest colistin co256 performance are depending on the mueller hinton agar plate used as described in the supplement insert (ref.16266, version a)- cis012.
for the enterobacteriaceae strains, the first results of the manufacturer’s investigation state that the performance of etest colistin co256 are conformed if used in conjunction with the mhe agar (from the manufacturer) with a good concordance rate compared to broth-micro dilution (bmd) method.
there is a potential of false susceptible results on etest colistin co256 ww (ref. 537300-537308) with some mueller hinton agar (except with the mhe agar from the manufacturer for the enterobacteriaceae strains).
these data need to be confirmed by the investigations ongoing.
the manufacturer requests users to take the following actions:
for enterobacteriaceae strains, users can continue to use the affected lots of etest colistin co256 (ref. 537300- 537308) for diagnostic purposes, only if it is used with mh-e (mueller hinton-e agar from the manufacturer’s ref. 413822-413823-413824-413825) agar. if not, or if users test other strains than enterobacteriaceae strains, the manufacturer recommends users to restrict its use to epidemiological surveys.
among tests previously performed, identify any possible false susceptible results, analyze the related risks and determine appropriate actions if relevant.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 2 august 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biorad ih-com kit full version
it has come to our attention that medical device manufacturer, biorad, has initiated a field safety corrective action concerning ih-com kit full version (data management and result interpretation software), with product reference 009000. the affected software versions are 03.0.43 / 03.0.52 / 03.0.59.
according to the manufacturer, in case of not interpretable results in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software does not include the reaction of this well (result code -30) when sending the results to the laboratory host. the issue can only occur if some specific conditions are met.
the described issue could lead to the interpretation of the abo group only based on the results of the anti-a and anti-b wells without taking into account the result of the anti-ab well of the concerned id-cards.
the analysis of this issue led to the conclusion that a residual risk exists for newborns for whom abo group is only determined through abc forward grouping (no reverse grouping performed). in the worst case scenario, a mixed field result (“dp”) in the anti-ab well in addition to a non detectable mixed field in the other wells (anti-a or anti-b), could lead to assigning a wrong abc group to the newborn based on the mother’s group.
the manufacturer advises users to immediately implement protective measures as follows:
ensure that the "second reading" option of ih-com is activated at least on discrepant results
in case of "abo not interpretable" in ih-com due to a reaction "?" or "+/-"or "dp" in the anti-ab well, the operator must open the "abo" scrollbar and select manually "abo not interpretable" before saving and sending the result to the host.
according to biorad, this issue will be permanently corrected through the deployment of the next ih-com software version.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 12 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: diamed lyra mp reader ii
it has come to our attention that medical device manufacturer, diamed, has issued a field safety notice concerning an automated blood grouping system - lyra mp reader ii [model number: 854002].
the manufacturer became aware that, in exceptional circumstances, the blood grouping system may incorrectly assign the results of the previously read microplate to the microplate being processed. in this specific context, the misallocated results are displayed in black and white instead of colour as would be expected. this issue could in the worst case lead to a mismatch between the test result issued and the true result of the sample.
according to the manufacturer, the potential for reporting an erroneous result is very limited because the occurrence of the issue is dependent on several exceptional random factors operating together.
the manufacturer advised users to use an empty microplate for balance purpose and deactivate the automatic validation of results for the system. the users should also check the colour of the results displayed before validation and should not validate the results if the images of wells appeared in black and white. as a permanent solution, the manufacturer will release a software update.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 july 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: diamed test cells for red cell antibody screening
medical device manufacturer, diamed, has issued a field safety notice concerning its test cells for red cell antibody screening. the product names (catalogue numbers) of the affected devices are as below:
id-dia (diego) positive (004134); id-diacell sf (003640); id-diacell pool (003630 / 003631); id-diacell abo/i-ii (003610); id-diacell abo/i-ii-iii (003618); id-diascreen i-ii-iii-iv-vp-vip (004316); id-diacell i-ii (003613); id-diapanel (004114); id-diacell i-ii-iii (004310); id-diascreen i-ii-iii-iv (004311); id-diacell i-ii-iii asia (003614); id-diascreen prophylax (004330); id-diapanel plus 6 (004414); id-diacell i-ii (003613vj); id-diapanel (1-11) (004114vj ); id-dia positiv (004134vj); id-diacell i-ii-iii (004310vj)
the manufacturer has identified unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the above mentioned products. this phenomenon is observed randomly between batches, and also within single batches.
according to the manufacturer, a risk assessment has been done, and the conclusion is that this unexpected result requires further confirmation testing before a final transfusion decision is made. negative results can be reliably accepted as negative.
the manufacturer advises affected users of the following:-
in case of doubtful reactions, re-test with a new kit.
if the results remain in doubt, send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 14 february 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bioconnect optiflow anastomotic connectors
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning optiflow anastomotic connector manufactured by bioconnect systems. the affected catalogue numbers are cs3203, cs4204 and cs4205.
according to the manufacturer, the optiflow anastomotic connector may be inadvertently dislodged (moved from the intended position) during percutaneous balloon assisted interventions to open a thrombosed fistula. the optiflow may get caught on or attached to the balloon if the balloon is not fully deflated during the interventional procedure. the optiflow may then dislodge or move during advancement or retraction of the balloon.
the manufacturer supplemented that optiflow dislodgement may result in serious injury or death to the patient if the optiflow is not captured and removed following inadvertent dislodgement as it may travel through the upper venous circulatory system, the heart and into the pulmonary circulatory system.
to prevent possible dislodgement of the optiflow anastomotic connector, bioconnect advised all customers to:
only use appropriately sized percutaneous transluminal angioplasty (pta) balloons during all intervention procedures for a thrombosed fistula.
use a maximum 3mm diameter balloon across the anastomosis for any planned pta balloon interventions of patients with a 3mm optiflow.
use a maximum 4mm diameter balloon across the anastomosis for any planned pta balloon interventions with patients with a 4mm optiflow.
carefully follow the instructions for use for the pta balloon and do not to advance or retract the balloon unless the balloon is fully deflated.
when advancing or retracting a compliant balloon across the anastomosis ensure the inflated balloon diameter is not greater than 4mm for the 4mm optiflow or 3mm for the 3mm optiflow
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 22 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biosensors biomatrix neoflex
it has come to our attention that medical device manufacturer, biosensors, has initiated a field safety corrective action concerning its biomatrix neoflex.
in specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action. if not identified prior use, the hub cracking may potentially lead to treatment delays or complications. the manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013.
the manufacturer advises users to identify, quarantine and return affected products.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 16 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biosensors biomatrix flex and biomatrix neoflex coronary drug eluting stent systems
medical device manufacturer, biosensors, has issued a medical device safety alert concerning its biomatrix flex and biomatrix neoflex coronary drug eluting stent systems.
the manufacturer is initiating a voluntary recall on certain units of biomatrix flex and biomatrix neoflex coronary drug eluting stent system (des) due to potential balloon burst below the rated burst pressure.
the manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, the manufacturer concludes that the compromised balloon performance was caused by certain characteristics in the manufacturing process. according to the manufacturer, the production lots manufactured between october to december 2015 could have been similarly affected.
the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient’s state of health during percutaneous coronary intervention.
patients who have already been implanted with an affected device are not impacted by this field safety corrective action.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 march 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biosensors international axxess drug eluting coronary bifurcation stent system
medical device manufacturer, biosensors international, has issued a field safety notice concerning 4.0 x 9mm model of axxess drug eluting coronary bifurcation stent system (axbf-4009) (lot numbers: w13090159 and w13080132).
several cases with deployment difficulty have been reported to biosensors international group to date, concerning the affected device. physicians in these cases found it either difficult or impossible to pull back the deployment actuator. this could potentially lead to a sub-optimal deployment. in most cases, the stent was successfully deployed, resulting in a positive clinical patient outcome. in the remaining cases, deployment was aborted and patients were administered alternative treatment, with positive patient outcomes. there have been no reports of adverse patient events.
the manufacturer has the following recommendations:
for all successfully implanted devices, no action is necessary and patients should continue to be managed in accordance with standard patient management protocol.
quarantine and return any remaining stocks of affected product.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 13 december 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biosensors international biopath 035
medical device manufacturer, biosensors international, has issued a field safety notice concerning biopath 035, with the following details:
model bpth-35-60100l (balloon diameter 6.0 x 100mm length – catheter length 135cm)
all lot numbers for this model manufactured prior to november 2014 are affected.
the manufacturer has received a report regarding a compatibility issue with the recommended sheath introducer size. the product is currently labelled for a 5f sheath introducer compatibility when the product specification is indicating a 6f recommendation.
according to the manufacturer, this mislabeling has no impact on patient safety but it may lead to a prolonged procedure. patients who have already been successfully treated with an affected device are not impacted by this action.
the manufacturer advises users to identify and quarantine the affected products. they will contact the affected users to arrange the corrective action.
according to the local supplier, the affected product is distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 february 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bitmos sat 805 and sat 816 pulse oximeters
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning sat 805 and sat 816 pulse oximeters manufactured by bitmos.
according to the manufacturer, the affected products may stop monitoring, providing dashes on the display and not providing an audible or visual notification to identify the change in state.
the manufacturer advises the affected users to suspend the use of the products immediately and return the affected products for software update.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con213146
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Press release: recall of two batches of one step hcg pregnancy test
the department of health (dh) today (january 14) drew public attention to the recall by the therapeutic goods administration (tga) of australia concerning the one step human chorionic gonadotropin (hcg) pregnancy test (batch numbers: 20150314 and 20140406) manufactured by blue cross bio-medical (beijing) co ltd, as they may give false negative results.
the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the tga of australia. according to the alert, there were complaints lodged by the users about false negative results of the product. results of subsequent testing undertaken by the tga have shown that these two batches do not comply with the claim in the instructions for use, which specify that "in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected."
batch 20150314 has failed to detect hcg in human urine at concentrations of 10, 25 and 50miu/ml levels while batch 20140406 has failed at hcg concentrations of 10, 25, 50 and 100miu/ml.
a spokesman for the dh explained that false negative results in the worst case can result in misdiagnosis and significant harm.
"although preliminary enquiry with the manufacturer reveals no evidence of the affected product having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the product from abroad or from internet purchase. the public is advised to stop using the concerned batches of the product and seek the advice of healthcare professionals if in doubt," the spokesman said.
so far, the dh has not received any local report of adverse incidents arising from use of the product.
ends/thursday, january 14, 2016issued at hkt 19:57.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bomimed. disposable resuscitators
the health canada (hc) posted a recall notice concerning disposable resuscitators manufactured by bomimed, inc.
according to the manufacturer, during in-house testing, it was discovered that if the maks were squeezed too hard, the plastic shell could crack, resulting in the inability of the mask to ventilate.
for details, please refer to hc website:
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php
if you are in possession of the product, please contact your supplier for necessary actions.
posted 15 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: boston scientific cognis®, teligen®, incepta™, punctua™, and energen™ crt-ds and icds, and latitude® remote patient monitoring system
medical device manufacturer, boston scientific, has issued a letter to physician to explain changes in lead configuration preferences and new test methodology in cognis®, teligen®, incepta™, punctua™, and energen™ defibrillator families, and clarifies how to interpret test result differences from prior defibrillator-lead combinations.
current boston scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and latitude monitoring system via the daily measurements feature. a measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a “red alert” within latitude (if activated). however, the measured value that prompted the alert is not displayed. similarly, out-of-range impedance measurements are not plotted on programmer or latitude trending graphs. boston scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue.
if you are in possession of the affected products, please contact boston scientific technical services for instructions on how to obtain more detailed shock lead impedance information when needed.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: boston scientific scs remote control (rc), charger, external trial stimulator, trial patient belt & charger belt
medical device manufacturer, boston scientific, has issued a medical device field correction concerning scs remote control (rc), charger, external trial stimulator, trial patient belt & charger belt.
boston scientific is distributing the written/ hard (english & french) copies of patient directions for use (dfus) to patients in canada who have the affected devices. no product is being recalled and no product should be returned to boston scientific in connection with this issue.
according to local supplier, hong kong is not affected by this alert. if you are in possession of the affected products, please contact boston scientific for necessary actions.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.