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 healthcare diagnostics has confirmed a decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems. this under-recovery has been observed in plasma samples with high bnp and tsh-3 values that require dilution to achieve results within the reportable range on the advia centaur and advia centaur xp systems.
Acción
Siemens is providing work around instructions for users to follow.
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
In some cases, the kleenspec disposable vaginal speculum may become damaged during shipping and handling, which may cause them to break during use.
Acción
Inspect stock and return damaged devices to Welch Allyn Australia.
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 alaris pump module may experience intermittent motor stall. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates.
Acción
CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion.
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
Architect toxo igg reagent lots 15070li00 (list number 6c19-25) are showing reduced specificity which may cause a shift to higher iu/ml values leading to increased grayzone and/or reactive results. the assay sensitivity is not impacted and current data indicated that no other lots are affected.
Acción
Quarantine and discard affected products. Abbott recommends discussing previous results with Laboratory Management and healthcare providers to determine if any further testing is required.
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
Guideliner catheter is being recalled due to a regulatory compliance issue. guideliner catheter has now been cancelled from the australian register of therapeutic goods (artg) because it should have been classified as a class iii medical device, not a class iia medical device in accordance with the therapeutic goods (medical devices) regulations 2002. the guideliner catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a class iii device to provide assurance of its quality, safety and performance. in particular, the tga has not been provided with appropriate data on the design verification and validation of the device necessary for a class iii classification.
Acción
Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).
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 confirmed analytical sensitivity values greater than 0.3mlu/ml described in the instructions for use when evaluating multiple lots of the advia centaur fsh assay and calibrator b on the advia centaur and advia centaur xp system.
Acción
Siemens is providing work around instructions for users to follow.
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
Beckman coulter has confirmed that the stability, while frozen, for the access folate calibrators may produce falsely elevated results which could mask a folate deficiency. product number a14207 may experience this issue at 12 months, and product number a98033 at 6 months.
Acción
Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.
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
There is a potential that the analyte comments may be deleted if the specific analyte is not counted in the mask. this risk is avoided in the case that the user makes comments against the “blood film comments” analyte for reporting blood film comments. the differential keyboard orders a profile that contains all of the additional blood cell types that can be manually counted. in many instances these additional cell types will not be identified in the count and will not receive a result (eg blasts, myelocytes, etc). the expected behaviour is that if a cell is not counted, then these analytes will be removed from the profile when the final count is accepted.
Acción
Roche is providing work around instructions until a software upgrade can be implemented to permanently fix the issue.
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
There is a potential for incorrect handling of extra-long result messages that are sent form the cobas® 8000 data manager and received into it 3000 using a “v2” instrument driver. this is applicable for messages that are greater than 33 results in length per episode and if the configuration of the predefined buffer size is not optimal. the “v2” instrument drivers for cobas® 8000 use a buffer to ensure that extra-long result messages are processed correctly. if this buffer is not configured for the specific driver that is installed, then there can be a mismatch in the amount of data that is truncated. the effect of this being that results and flags after result #33 in the string may be delayed and in some cases may not be reported to cobas® it 3000.
Acción
Roche are providing work around instructions until a software upgrade can be implemented to permanently fix the issue.
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
This is an update to the 'hazard alert' letter dated 24 may 2011, pertaining to the eon mini model 3788 and brio model 6788 implantable pulse generators (ipgs) inner battery cracking issues. st. jude medical received reports eon mini and brio ipgs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
Acción
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.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
The forceps inside the packaging may be the incorrect configuration. specifically, the outer packaging indicates the product is dbf-2.4sn-230-s (has non-spiked forceps head), but the forceps inside are actually dbf-2.4sl-230sp-s (has spiked large forceps head).
Acción
Quarantine and return affected devices to Cook Medical.
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
Three issues requiring correction have been identified by the manufacturer:1. during reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. the safety catch mechanism does not activate due to the counteracting force of the remaining spring. as a consequence the u-arm moves down uncontrolled. the manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system. 2. during installation all 3 screws for one sib chain wheel were found loose. if all 3 screws of one of these wheels loosen completely, the detector carriage and/or the tube carriage can move down uncontrolled until stopped by the corresponding end stop.3. during in-house testing it was detected that the life time of the wire rope is significantly lower than the specified 10 years. the replacement of the wire rope every 3 years is required.
Acción
Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and Instructions for Use.
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
Alaris pump module model 8100 that contains the door assembly with keypad part number tc10005926 may be at risk of the door keypad overlap separating from the keypad assembly. when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
Acción
The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.
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
Anomalous decreases in the average optical density (od) have been observed with certain kits within the lifecodes pak product line. the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
Acción
Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is required.
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 test kit was assembled containing two components, the wt control and the mu control, that were released for non-commercial internal use only.
Acción
Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available.
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
There was a possibility that the bolt used to secure the stem and neck of the apex modular hip may not have been included with the packaging prior to sterilisation and dispatch.
Acción
Quarantine and return affected devices to Global Orthopaedic Technology for replacement with unaffected 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
Tga's microbial testing of l-gel ultrasound transmission ge shows general microbial count exceeding the microbial standards for medicines (tgo 77) that are intended for cutaneous and mucosal use. such microbial levels constitute a moderate to serious health hazard for infection, especially if the ultrasound transmission gel is used for a non-intended purpose, e.G. an invasive procedure.
Acción
Customers to remove stock from use and contact the sponsor to arrange return of product. For more details, please see http://www.tga.gov.au/safety/alerts-device-l-gel-120816.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
There is difficulty firing the device which may result in an incomplete firing stroke that may result in incomplete staple formation.
Acción
Quarantine and return affected product to Johnson & Johnson Medical
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
There have been reports concerning quality control results outside of the expected ranges. siemens has determined that this issue is due to a decrease in the onboard stability of the ehv assay reagents. this issue will be identified by the quality control material.
Acción
Siemens is providing work around instructions for users to follow.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
There have been reports of leaking injectors on the empty sterile vial. hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. the injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process.
Acción
The sponsor is providing work around instructions to mitigate the risk.
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 agility beam limiting device (bld) does not support the use of dynamic multileaf collimator (dmlc) apex at this time. apex has not been integrated or classified as compatible for use with the agility. the use of these products together has not been verified or validated by elekta and they must not be used together. there are mandatory changes necessary to the agility bld interlock circuit to let you safely attach the apex device.
Acción
The customers are advised not to use Apex with Agility as the combined use could cause fatal injury, clinical mistreatment or damage to the equipment. At this time, it is noted that no Australian customers currently have an Apex installed.
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
Biomet spain orthopaedics s.L. has initiated this action following the investigation on a reported event. it has been confirmed that in a few cases the affected product does not properly fit in the acetabular cup.
Acción
Biomet Australia is contacting the treating/implanting surgeon regarding the issue so that the affected patient can be appropriately managed.
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 performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. it may happen in a very specific scenario when one operator is requesting a lih (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the lih (last image hold) in review monitor. the user would need to restart the system in order to regain acquisition capability.
Acción
GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue.
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
Monitoring and analysis of the clinical results of the smr l2 metal back glenoid component indicate that under certain conditions, for example rotator cuff failure or patient trauma, the polyethylene insert can disassociate. the total revision rate of the l2 version of the smr metal back glenoid component in australia is 6.78% at three years.
Acción
Lima is contacting all implanting/treating surgeons and advising them on how to manage patients implanted with the L2 component. For more details, please see http://www.tga.gov.au/safety/alerts-device-shoulder-smr-121030.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
Due to an incident involving the back rest on an ultima bath chair, the manufacturer has updated the instructions for use (ifu) on adjusting the back rest and pre-use safety checks.
Acción
FAS Therapeutic Equipment is providing customers with amended instructions for use advising that the Ultima Bath Chair should not be adjusted while occupied.