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: abbott alere nt-probnp for architect controls
medical device manufacturer, abbott laboratories, has issued a medical device safety alert concerning its alere nt-probnp for architect controls. the affected devices are identified as follow:
list number: 2r10-10;
lot number: a) 902917627; b) 902918346
expiration date: a) 19 december 2018; b) 16 february 2019
udi number:
a) (01)05055845400404(17)181219(10)902917627;
b) (01)05055845400404(17)190216(10)902918346
abbot laboratories becomes aware that the manufacturer of the alere nt-probnp for architect controls, axis-shield, has identified a stability issue that may lead to quality control values falling outside of expected ranges prior to assigned expiry date.
according to the manufacturer, a potential delay may exist in the reporting of patient results due to quality control values falling outside of expected ranges. internal testing on patient samples showed no atypical bias for the impacted lots, therefore if quality controls are in range, patient results are not impacted.
if affected users have an alternate control lot available in inventory, they should immediately discontinue use of the affected control lot(s) and switch to the alternate control lot. they should also destroy any remaining inventory of impacted material according to their laboratory procedures.
if the affected users do not have an alternate control lot available in inventory and the current lot continues to generate valid qc results, they should immediately order a replacement control lot. they may continue to use the affected control lot(s) while following their current laboratory qc procedures. once they receive the replacement control lot, they may destroy any remaining inventory of impacted material according to their laboratory procedures.
product replacement is on-going.
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 4 september 2018.
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: abbott architect lactic acid
medical device manufacturer, abbott laboratories limited, has issued a medical device safety alert concerning its architect lactic acid [list number: 9d89-21; lot number (expiration date): 31497un14 (17 oct 2016); 09353un15 (12 feb 2017); 45216un15 (12 may 2017); 14596un15 (30 jul 2017); 37055un15 (12 oct 2017); 14782un16 (21 apr 2018)].
the manufacturer has identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21).
according to the manufacturer, the levels of interference observed at nac concentrations of 80 mg/l (0.49 mmol/l) and 800 mg/l (4.9 mmol/l) have been outlined in the field safety notice (fsn). patients undergoing treatment with nac may have falsely depressed lactic acid results.
the affected users are advised to take the following actions:
review the fsn with their medical director
taking the fsn into consideration, they may continue to use architect lactic acid reagent (ln 9d89-21)
retain the fsn for their laboratory records
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 october 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: abbott laboratories m2000sp instrument
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning m2000sp instrument, with affected list number 09k14. all assays run on the m2000sp instrument that require manual entry of calibrator and control expiration dates, lot numbers, and calibrator and control concentration values were affected.
according to the manufacturer, there was an issue on the m2000sp instrument software when information is entered incorrectly during the creation of a sample extraction test order. an issue may occur only when the correction is made to manually entered calibrator or control information after the operator have progressed beyond the "sample extraction: sample scan" screen and the operator do not re-scan the sample tubes and racks after data correction on the "sample extraction: assay detail" screen. an issue with the m2000sp instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved. this software issue will occur if some specific steps are followed.
furthermore, the manufacturer advises users that when entering calibrator or control information on the sample extraction: assay details screen, verify that the information is correct prior to proceeding to tile next screen. if identifying that the entered information is incorrect, users can correct the information by following options or steps suggested by the manufacturer. the manufacturer will deploy a new corrective software upgrade by the end of first quarter 2013.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 17 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: abbott laboratories architect anti- hbc ii reagent
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning architect anti- hbc ii reagent kit, with the following details:
list number: 8l44-25; 8l44-30; 8l44-35;
lot number: 42072li00; 42072li01; 42253li00; 42253li01; 42255li00; 42255li01; 42256li00
according to the manufacturer, the affected product shows lower calibrator, control and sample relative light unit (rlu) values, potentially leading to reduced specificity and increased false reactive results. internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. there is the potential for false reactive patient results but assay sensitivity is not impacted.
the manufacturer advises users not to use the affected lots and destroy any remaining inventory of these lots according to their laboratory procedures.
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 2 march 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: abbott laboratories alkaline wash
medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning alkaline wash, with the following details:
list number: 9d31-20
lot number: 49059un14
expiration date: 4 march 2016
the manufacturer is recalling the affected product due to leaking and/or material received with loose bottle caps that may have leaked during shipment
the manufacturer has given the following advice to users: -
while wearing the appropriate personal protective equipment (ppe), visually inspect the inventory.
if users observe any signs of leakage or loose caps, they should discontinue use and dispose of any remaining inventory of those kits in accordance with their institution’s policies and procedures.
if users do not observe any signs of leakage or loose caps, they may continue to use the product following the precautions per the architect system operations manual and the safety data sheet.
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 18 may 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: abbott architect estradiol reagent
medical device manufacturer, abbott laboratories ltd, has issued a medical device safety alert concerning its architect estradiol reagent. [list number: 7k72; lot numbers: all].
the manufacturer has confirmed that the drug fulvestrant (faslodex) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results.
the potential risk to health applies only to patients being treated with the drug fulvestrant which may lead to increased estradiol results.
in worst case scenarios, falsely elevated estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy.
the manufacturer advises users that patients undergoing fulvestrant therapy should not be tested with the architect estradiol assay.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 april 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: abbott architect ict module
medical device manufacturer, abbott laboratory, has issued a medical device safety alert concerning its architect ict module. the affected devices are identified as follow:
list number: 09d28-03;
lot number: 180326;
expiration date: 26 december 2018;
udi: (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399.
the manufacturer has received customer complaints regarding higher than expected serum or plasma chloride results when using the affected products. based on an analysis of quality control (qc) data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected. the customer qc data do not indicate an issue with urine chloride results.
according to the manufacturer, the issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted. there is the potential to generate falsely elevated serum or plasma chloride results when using the affected products. there is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride qc results.
the affected users are advised to immediately discontinue the use of the affected products. they should destroy any remaining inventory of the impacted lot number according to their laboratory procedures. they also should discuss with their medical director and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
product replacement is on-going.
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 4 september 2018.
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
Urgent field safety notice: abbott m2000sp instrument
medical device manufacturer, abbott molecular, issued an urgent field safety notice concerning m2000sp instrument (list number: 9k14).
there have been two reported instances in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated or caught fire. in both cases the event was contained within the lower cabinet of the m2000sp. there were no reported injuries. abbott molecular is actively investigating this issue.
according to the local supplier, the affected device has been distributed to hk. abbott molecular recommends users to examine the liquid waste sensor during daily maintenance, and stop using the system when any unusual conditions noticed and contact the local supplier for service.
if you are in possession of the affected product, please contact your supplier immediately 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
Field safety notice: abbott molecular bar code scanner user’s guide
medical device manufacturer, abbott molecular inc., has issued a field safety notice on abbott molecular bar code scanner user’s guide list number: 6l-88-03, 6l88-04, 6l88-05, 6l88-06, 6l88-07, 6l88-08, 6l88-09.
according to the manufacturer, internal investigation has identified that within the user’s guide, the section modifying the keyboard format for bar code scanner ln 6l89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format.
the manufacturer explained that incorrect bar code scanner language configuration could result in the keyboard and bar code scanner not having the same language formats. this could potentially lead to incorrect patient sample identification. independent of this language configuration issue, the bar code scanner is working as expected.
the local supplier confirmed that scanners with the affected list numbers have not been distributed in hong kong. if you are in possession of the products, 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
Field safety notice: abbott molecular hcv genotype ii m2000 system row combined application cd-rom version 3.0
medical device manufacturer, abbott molecular inc., has issued a field safety notice concerning hcv genotype ii m2000 system row combined application cd-rom version 3.0 (list no: 8l36-03).
according to the manufacturer, internal software development testing identified that when running the hcv-gt ii assay, if four or more genotype calls are present for a sample, the software does not generate a result (printed or displayed). instead a blank field is reported.
this observation will only occur when running:
m2000rt instrument system software v4.0 and v5.0 and
hcv genotype ii m2000 system row combined application cd-rom version 3.0.
there have been no reports from customers in regards to this observation.
if you are in possession of the products, please contact your supplier for necessary action.
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: abbott realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom
medical device manufacturer, abbott molecular inc., has issued a medical device safety alert concerning its realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom [list no.: 02n09 and 4n05-01; version 1.0 of the realtime high risk (hr) hpv m2000 system row combined application cd-rom]
according to the manufacturer, m2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the fluorescence signals during the amplification and detection process. the manufacturer has identified that the instrument noise lower limit validity parameter for the realtime hr hpv assay is set outside of the optimal setting to flag excess variability in fluorescence signal. therefore, in the presence of excess noise, incorrect results could be generated.
it is normal for instruments to have some variability in fluorescence signal (noise). however, one factor that could contribute to excess instrument noise is m2000rt lamp issues. a resolution has been identified and requires a change to the instrument noise validity parameter for realtime hr hpv assay.
the manufacturer will correct the issue in the next version of the assay software. affected users are recommended to follow the technical solutions mentioned in the field safety notice until an upgrade to the new software can be installed.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 02 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: abbott molecular vysis fish pretreatment reagent kits, paraffin pretreatment reagent kits & protease vials
medical device manufacturer, abbott molecular incorporation, has issued an field advisory notice concerning the vysis fish pretreatment reagent kit, [list number 02j03-032]; vysis paraffin pretreatment reagent kit, [list number 02j02-032]; paraffin pretreatment reagent kit ii, [list number 07j02-002]; protease i, 250mg x 2 vials, [list number 02j08-032] respectively.
the manufacturer identified protease vials that were under filled and over filled. this may result in under or over digestion of the specimens and controls.
according to the manufacturer, under or over digestion of specimens or controls could cause fish assays to be difficult to interpret or produce invalid/uninformative results. an invalid/uninformative control slide or specimen slide would result in the need to perform a repeat analysis with fresh control slides and specimen slide(s). there is no impact on results generated for slides that produce valid and interpretable results.
according to the local supplier, the affected devices were distributed in hong kong. for details, please refer to the attached field advisory notice. if you are in possession of the product, please contact your supplier for necessary actions.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
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: abbott i-stat pt/inr cartridge
the therapeutic goods administration (tga), australia issued a medical device safety alert concerning i-stat pt/inr cartridge, manufactured by abbott point of care division. the affected list number is 3p89-24, and the affected lot numbers are 1 c103139 to and including c13270a.
abbott point of care has determined that the i-stat pt/inr cartridge lots have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr.
the manufacture advises users to destroy unused stock. any remaining stock will be replaced by abbott. also, the manufacturer advises that a review of previous results may be performed at the discretion of the laboratory manager.
for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01119-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 november 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: abbott i-stat 1 analyzer system - g3+ cartridge
health canada has issued a medical device safety alert concerning i-stat 1 analyzer system - g3+ cartridge, manufactured by abbott point of care inc. the affected model number is 03p78-25, and the affected lot number is n13183.
the manufacturer has determined that i-stat g3+ cartridges from cartridge lot number n13183 have the potential to exhibit incorrectly elevated partial pressure of carbon dioxide (pco2) and depressed ph results. the pco2 results can be elevated by 10 to 25 mmhg while the ph results can be depressed by 0.10 to 0.15.
all other g3+ cartridge lots are unaffected by this issue.
for details, please visit the following health canada website:
http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38453r-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 21 march 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
Field safety notice: abbott vascular rx accunet embolic protection system
medical device manufacturer, abbott vascular, has issued a field safety notice concerning the rx accunet embolic protection system.
abbott vascular has discovered that certain lots may exhibit difficult removal of the peel away sheath due to a higher than normal wall thickness. there have been no adverse patient effects reported as a result of this issue. this action does not affect patients having successfully undergone endovascular carotid procedures. however, if an affected device is used it may result in difficulty initiating the peel away sheath, possibly resulting in additional device maneuvers and or a delay in procedure. this action does not affect any inventory beyond the units identified here.
according to the local supplier, hong kong is not affected.
if you are in possession of the affected products, 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: abbott mitraclip mitral valve repair system
medical device manufacturer, abbott vascular, has issued a field safety notice concerning mitraclip mitral valve repair system (product number msk02st).
abbott vascular has received a total of 4 reports since 2008 where the actuator knob of the clip delivery system was incorrectly turned in the clockwise direction during clip deployment. in the event that the actuator knob is incorrectly turned, the device may incur damage that prevents the deployment of the clip. additional medical intervention or conversion to surgery may then be required.
the current inventory of product is acceptable for safe use following the steps highlighted in the instructions for use (ifu). patients that have had clips successfully implanted are not affected by this action.
the manufacturer advises all users to consult the approved ifu that were distributed with each device, which contains important information for the proper clip deployment steps. specifically, step 17.2.2 states: “turn the actuator knob of the dc approximately 8 turns counterclockwise. if it is difficult to turn the actuator knob, confirm that the arm positioner moves freely. retract the actuator knob after it is fully unthreaded.” subsequent to this step, the following warning appears: “failure to stop turning the actuator knob when resistance is felt or turning the actuator knob in the clockwise direction may result in inability to deploy the clip.” furthermore, the manufacturer will add a directional arrow on the actuator knob of newly manufactured devices to aid in proper clip deployment.
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 28 february 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: abbott vascular mitraclip clip delivery system
medical device manufacturer, abbott vascular, has issued a medical device safety alert concerning its mitraclip clip delivery system [product number: msk02st]. the system contains the clip delivery system [product number: cds02st] and the steerable guide catheter [product number: sgc01st].
the manufacturer has recently received nine reports of cases on clip delivery system devices that contain the one-way actuator knob [lot number 50714u1 and greater] where a user attempted implanting a mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in surgical interventions and, in one case; the patient expired post-operatively due to severe co-morbidities.
the manufacturer’s investigation determined that a mandrel fracture may occur if tension is present on the mandrel when turning the actuator knob to deploy the clip. the tension is present if the arm positioner is on the “closed” side of neutral, as opposed to being in the neutral position during clip deployment.
the manufacturer is revising the mitraclip ifu clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the clip. the manufacturer will train all mitraclip implanters on the revised instructions. there is no need to return any product to the manufacturer.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 february 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: alere triage cardio 3
medical device manufacturer, alere, has issued a medical device safety alert concerning triage cardio 3 with catalogue number 97400 and lot number w53658b.
according to the manufacturer, the affected product was investigated in response to date observed as part of the manufacturer’s routine product performance monitoring program. this lot shows lower than expected result for bnp, ckmb and troponin i which in turn could result in an increased rate of false negative results. testing of external controls would enable the lab to detect if this lot was giving lower than expected results at the time of testing.
the manufacturer advises users of the followings:
if users have questions about previously reported results, they should consult with resident clinical expert or physician in the setting where the test was performed.
users should discontinue use of and discard the affected products. product replacement will be arranged by the manufacturer.
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 february 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: alere inratio2 pt/inr professional test strips
the u.S. food and drug administration (fda) and the australia therapeutic goods administration (tga) posted a medical device safety alert concerning inratio2 pt/inr professional test strips, manufactured by alere.
there were complaints of patients who had a therapeutic or near therapeutic inr with the alere inratio2 pt/inr professional test strip but a significantly higher inr (outside of therapeutic range) when performed by a central laboratory. the manufacturer has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. the reason for the adverse event reports was significantly different test results between the alere inratio2 pt/inr professional test strip and the local laboratory plasma inr test. the alere inratio2 pt/inr professional test strip results were between 3.1 – 12.2 inr units lower than the laboratory result. there may be risk of inaccurately low inr result.
the manufacturer has advised users to immediately stop using the alere inratio2 pt/inr professional test strips. it has also advised users to use an alternative method to perform pt/inr testing, such as a plasma-based laboratory inr test, an alternative alere product, or an alternative point-of-care monitoring system from a different manufacturer. the manufacturer is notifying healthcare providers of an update to the limitations of use for the inratio 2 pt/inr tests strips. consumers are being provided with a safety alert notification advising of potential issues with the accuracy of the device and the correct clinical practice with regard to medication dosing. furthermore, the manufacturer will transition customers from the current alere inratio2 pt/inr professional test strip to the alere inratio pt/inr test strip (pn 100139).
professional test strip to the alere inratio pt/inr test strip (pn 100139).
for details, please refer to:
the fda website
http://www.Fda.Gov/safety/recalls/ucm396219.Htm
and the tga website
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00471-1
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 7 may 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: alere testpack + plus with obc hcg urine
it has come to the attention of the medical device control office that several maternal and child health centres of the department of health have reported incidents of false negative results relating to testpack + plus with obc hcg urine pregnancy test kit manufactured by alere.
the issues have been reported to the local supplier, zenith medical co. ltd. and investigation is underway.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 27 july 2016.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
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: alere sd bioline hiv ag/ab combo
medical device manufacturer, alere, has issued a medical device safety alert concerning its sd bioline hiv ag/ab combo [product codes: 03fk30, 03fk35; lot numbers: 03bda003a, 03bda004a, 03bda005a, 03bda006a, 03bda006b, 03bdb001a, 03bdb001b, 03bdb001c, 03bdb002a].
the manufacturer has received two performance complaints of sd nioline hiv ag/ab combo in february 2017 from kyrgyzstan. they investigated the complaints and confirmed that the affected lots did not meet the performance claim for analytical sensitivity of p24 antigen (claimed detection limit in the package insert: 2iu/ml, however the affected lots detect a concentration of 16 iu/ml.
according to the manufacturer, when performing as expected, the p24 component of the assay may enable the detection of the infection about 7 days before the antibody results become positive. if a patient is in very early diagnostic window period, the lower p24 sensitivity of the affected lots may reduce the detection period by one or two days, with the possibility of a false negative result.
if a false negative result occurs, it is possible that treatment of a patient that is hiv positive could be delayed and further transmission of the infection to sexual partners or through blood transfusion could occur.
the users are advised to take the following actions:
examine their inventory immediately to determine if they have product on hand subject to this action. if so, quarantine such product(s).
remove the products subject to this voluntary recall, and dispose or destroy the product.
for patients of which negative results on p24 antigen were obtained, conduct confirmatory assays.
according to the local supplier, the affected products are distributed in hong kong and product recall is on-going. there was no adverse event reported.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 5 may 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: alere triage rapid diagnostic test system
the united states food and drug administration (fda) has issued a class i recall concerning triage cardioprofiler panel (pn 97100cp), triage cardiac panel (pn 97000hs), triage profiler sob panel (pn 97300), triage bnp (pn 98000xr) and triage d-dimer (pn 98100), manufactured by alere san diego, inc..
identified lots, manufactured from 06/12/2011 to 04/08/2012 and distributed from 09/08/2011 to 06/05/2012, may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. certain lots affected have an increased frequency of troponin i results >0.05 ng/ml for samples which are found to be below 0.05 ng/ml upon additional testing. these false positive and false negative results are unpredictable within lots and may not be detected by quality control testing.
there have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. this product may cause serious adverse health consequences, including death.
for details, please refer to fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm311387.Htm and
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm311405.Htm.
f you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 12 july 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: idev technologies supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f)
the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f), manufactured by idev technologies.
according to the manufacturer, there were reports of a rare event in which the catheter tip was pulled off during use. the manufacturer has determined that the failure to adhere to the instructions for use appeared to be the root cause of these events.
specifically, if the thumb slide on the catheter handle is not retracted and locked prior to catheter withdrawal, per the instructions for use, the catheter tip may catch on the introducer sheath and may be pulled off the catheter body. removal of the detached tip may be necessary, as determined by the physician. to date, the manufacturer is not aware of these incidents occurring when the instructions for use are followed and, no injuries have been reported.
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 product, please contact your supplier for necessary actions.