Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been reported that a wound drainage bottle from a varivac wound drainage set was found to be cracked or split through the green connector on the top of the bottle reservoir causing a loss in vacuum in the bottle reservoir.This recall action was carried out prior to approval of the recall strategy by the tga.
Acción
All affected InLine products have returned to the distributor.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The flux used to solder the printed circuit board was not entirely cleaned off resulting in the increase potential for retention of moisture. in high humidity environments this could result in the device failing.This recall was undertaken prior to notification to the tga.
Acción
International Care withdrew potentially affected units from wholesalers and retailers.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The vitros microslide cartridge is made up of the cartridge body and an anti-backup platen (abp). the purpose of the abp is to keep the stacks of slides in the correct position for dispensing. ortho clinical diagnostics have received reports associated with abp failing to advance, jamming or failing to stay locked in place within the cartridge. when this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly.
Acción
Ortho Clinical is providing users with work around instructions to resolve slide dispense issues. Users are advised to replace the affected unit and contact Ortho Clinical for a replacement if they are unable to resolve a slide dispense issue by repositioning the ABP. This action has been closed-out on 12/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Werfen australia's investigation of recent customer complaints determined that an acl top family instrument can experience carry-over that causes shortened aptt clotting times on patient and/or quality control results. carry-over can occur when a hemosil synthaasil aptt reagent (pn 0020006800) is located in the same reagent rack as certain other hemosil reagents. the carry-over is introduced during the liquid height check that is performed upon rack insertion and is dependent on material position, the order of rack insertion, and the sequence in which the assays are performed.
Acción
Werfen is providing users with work around instructions to follow to mitigate the potential for this issue to occur. The requirement for a look back at previously reported results should be determined by the laboratory director. A software update is currently under development to correct this issue permanently. This action has been closed-out on 10/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ormco have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
Acción
Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Cell marque cdx-2 is used to aid in the differentiation of colorectal adenocarcinoma and lung adenocarcinomas. the cdx-2 antibody typically stains the nuclei of colorectal carcinoma cells but not lung adenocarcinoma cells. abacus has advised that the cdx-2 antibody may exhibit a light sporadic, focal, nuclear staining in a limited number of lung adenocarcinomas such as those with enteric differentiation, and may demonstrate slightly stronger staining than other lots.
Acción
Abacus ALS is requesting users to destroy affected stock. Replacement units will be provided as soon as possible. The requirement for a review of patient results reported from this lot should be determined by the laboratory director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has confirmed that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid, results generated with this readypack are not affected. however, due to the sporadic nature of the issue, successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.
Acción
If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The manufacturer has advised that there has been a higher than anticipated number of reports of post-injection knee pain and swelling. in some cases an increase in the intensity of the symptoms have been reported. pain, swelling and stiffness may limit mobility or use of the limb. recovery time might be increased and moderate to severe patient discomfort may result. some patients may have swelling due to varying degrees of effusion and which may require aspiration. most patients involved with the reported complaints recovered within the listed timeframe in the ifu and known from the clinical studies of the product. few patients had a protracted recovery time beyond 3 weeks after injection.
Acción
Please report any issues or adverse reactions to the TGA (refer to "Report a problem with a medical device" http://www.tga.gov.au/safety/problem.htm#device) and to Smith & Nephew Surgical. Customers with affected units are requested to advise Smith & Nephew so that replacement stock can be arranged.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Investigations by the manufacturer have confirmed that cartridges within the affected batch may contain individual discs with insufficient amount of antibiotic, resulting in smaller than expected zones of inhibition. continued use of the affected lot could result in false indication of resistance to meropenem.
Acción
End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of hemocue hb 201 microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture the cuvettes will not fill properly and no measurement will be given.
Acción
HemoCue is asking users to discard any affected microcuvettes as per the Instructions for Use. Replacement of affected units can be arranged by consulting HemoCue.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
During the validation of a new instrument, testing revealed that use of a gravity steam cycle with one of the listed instrument trays did not produce the sterility assurance level (sal) of 10-6 required by industry standard (ansi/aami st77:2006). a subsequent investigation of all medtronic xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of sal 10-6 during gravity steam sterilization cycles.
Acción
Hospitals that use GRAVITY steam sterilisation cycles are requested to quarantine all stock immediately. Hospitals that use PREVACUUM steam sterilisation are advised that they can continue to use the trays once they have attached a label stating 'PREVACUUM ONLY' provided by Medtronic.
A Medtronic representative will be in contact with customers to arrange for replacement with a new tray with updated labelling.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of glusoce rt microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture which in some cases may lead to a measurement deviating +/- 2mmol/l.
Acción
HemoCue is asking users to discontinue use of the affected lots as the affected microcuvettes may display a measurement deviation of +/- 2mml/L. Affected product will be replaced by HemoCue.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been reported that the pouch, which should describe the elastic as a "5h (3/8") 14 oz." on the back actually describes the product as "7b (5/8") 2 oz." elastic instead. although an inconvenience, there are no safety or efficacy issues involved with this product.
Acción
Ormco is requesting users return affected devices for replacement.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The compatibility chart on the product label and or reference chart literature/poster indicates that the size 6 posterior stabilized (ps) femoral component is compatible with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts. the size 6 ps femoral component is not cleared for use with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts, and should not be implanted with either of these size 4 insert.
Acción
Existing OR Reference Charts on posters should be discarded and replaced with revised OR Reference Charts, which will be supplied to the customers by JJM sales representatives.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ge’s disposable general purpose 9fr temperature probe is intended for oesophageal and rectal use only. it has been brought to the attention of ge healthcare that some users are inserting the probe nasally which may result in epistaxis (nose bleed).
Acción
GE Healthcare is providing users with an update to the Instructions for Use (IFU) and pouch label to clarify insertion locations.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Through post market surveillance data review, edwards lifesciences has identified a potential health risk to patients undergoing by-pass surgery when an anastaflo intravascular shunt is used. edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. there have been no reports of injuries in any of these complaints. no events have been reported in australia.
Acción
Customers are asked to quarantine affected stock and return all devices with remaining shelf life to Edwards Lifesciences. Customers can contact Edwards Lifesciences to obtain replacement product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Sterrad 100nx system cassettes are designed with a leak indicator on the outer package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes. the manufacturer has determined it does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the sterrad 100nx system cassette's 15 month shelf life.
Acción
Johnson & Johnson Medical (JJM) is requesting end users to wear additional safety equipment (protective gloves and eye wear) in the event of handling product with an expired leak indicator as a precautionary measure for devices with an expiration date prior to 1 November 2014. End users are also requested to check for signs of indicator colour change or liquid leakage prior to opening the package. If the white indicator has turned red or a liquid leak is observed, customers are asked to dispose of the cassette immediately. Any indication of leakage should also be notified to JJM.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ge healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (piv) for venous flow measurements. the ductus venous piv measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. in case of negative flow patterns, the viewpoint calculated doppler piv for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21.
Acción
GE Healthcare is advising users to discontinue use of venous PIV for making any clinical decisions, in particular, discontinue use of the ductus venous PIV for first trimester risk assessment. GE Healthcare will be providing a software upgrade as a permanent fix.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
While the c-arc base rotation is moved manually and at the same time a motorised base rotation is initiated followed by a movement stop request the geometry of the system will reset. consequently the stand movements and table movements then will not be available for about 90 seconds. the table top will be free floating and can manually be moved in both longitudinal and transversal direction.
Acción
Philips is advising users not to initiate a motorised movement of the base rotation when it is moved manually. The system sees this as a conflict and will perform a Geo reset. A software update will be available in Quarter 4 2013.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Leica biosystems has received reports that the product may be contaminated with fungus. this issue could cause loss of staining sensitivity or obstruction of fluid delivery to the slide.
Acción
Leica Biosystems is requesting users to remove and discard remaining affected reagents. Affected product will be replaced by Leica Biosystems. A review of patient results reported from the affected lot should be undertaken at the discretion of the laboratory manager.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Smiths medical has received a complaint that a inner cannula package labelled as 7mm contained a 9mm inner cannula.
Acción
Smiths Medical is advising users to check the size embossed on the cannula before insertion. Users are being requested to notify Smiths Medical for a replacement if any 9mm cannula's have been packaged incorrectly.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Biocsl carried out confirmatory testing on all products potentially supplied with incorrect phenotype information ie, donor 1 was lu-a positive whereas the antigen composition sheet stated donor 1 as lu-a negative. in addition to confirming the lu-a inconsistency, testing identified that the donor was co(b) positive whereas the antigen composition sheet indicated donor as co(b) negative.
Acción
bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Biomerieux has advised that some units in lot 1001818920 of fluoprep (reference 75521) may be to too thick and is difficult or impossible to spread on the slide.
Acción
End users are requested to discard any product that is too thick to effectively use and contact bioMerieux to organise for replacement stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Some units did not pass the high voltage test during the final checking of the fabius by the manufacturer. investigations carried out revealed that on some power supply units, the required minimum clearance between an electrical component and the unit housing was not maintained. under the influence of mechanical forces (e.G., movement of the device), this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur, the standard required manual ventilation is possible, an acoustic alarm is generated and the indicators on the device flash.
Acción
As an interim measure, Draeger Medical is advising users to switch over to manual ventilation mode should users experience a failure of the automatic ventilation function. The power supply units will be replaced as a permanent correction.