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
Based on complaints, cordis has detected a higher frequency of users reporting difficulty with stent deployment of s.M.A.R.T. flex vascularstent system sizes 5x200mm and 6x200mm, compared to other sizes. inherently, longer stents have higher deployment forces, and the s.M.A.R.T.® flex vascular stent system 5x200mm and 6x200mm sizes have higher deployment forces than larger stent diameter sizes of the same length based on differences in the as-cut stent pattern. the most reported deployment difficulty is the inability to deploy the stent resulting in an intra-procedural delay while a replacement device is prepped. however, partial stent deployment may cause ischemia, or internal bleeding, which would require further intervention.
Acción
Cordis is requesting customers to check their inventory immediately and quarantine affected stock. Customers are further advised to contact their local sales representative for the return of the affected stock for a product replacement or credit. (Please note that replacements of the same sizes are not currently 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
Several issues have been identified with philips brightview, brightview x and brightview xct leading to a need to re-scan the patient:-brightview xct systems only:- motion controller emits the warning message; and- door interlock switch with x ray perform.For both brightview x and xct systems:- detector contacts head holder when performing patient unloadfor brightview, brightview x, and brightview xct systems:- jetstream freezes during gated planar scan.
Acción
Philips is notifying the affected users of these issues via this Customer Information Letter. Customers will be contacted by a Philips Field Service Engineer for implementation of the necessary software corrections free of charge.
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 identified that the couch rear subframe cover may not be strong enough in the area around the philips logo lettering to prevent cracking during normal operations. if the cover is impacted by excessive force as a result of contact with medical transportation equipment or accessories, the cover may crack, creating a potential for injury.
Acción
Philips is advising users to observe the cautions included in their system user documentation and retain the recall notification with the Instructions For Use (IFU). Users are further advised to contact Philips if there are indications that their system is not operating properly.
This action has been closed-out on 01/03/2018.
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
Bio-rad has observed that the values for the analyte haemoglobin a1c may gradually decrease over the shelf life of certain product lots.
Acción
Bio-Rad advises:-
1. Laboratory means and acceptable ranges may need to be re-established for HbA1C during the shelf life of the product;
2. Users are requested to obtain a revised copy of the Liquichek Diabetes Control package insert through the Internet at http://myeinserts.qcnet.com
Discard all previous versions of the package insert for these lots of product that they may have at each location and substitute those with the revised package insert.
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
Philips has identified that v60 ventilators with software version 2.20 may falsely detect that the blower motor has stalled. if this condition occurs, the software will cause the ventilator to shut down (vent inop) and display error code 100e. ventilatory support will cease. an audible high-priority alarm will sound continuously for at least 2 minutes when the v60 shuts down for any vent inop condition and is operating on battery power. if the v60 is connected to ac power (mains supply), the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator.Error code 100e only exists in v60 version 2.20 software. therefore, v60’s running version 2.10 software are not subject to this particular vent inop condition.To date, there have been no adverse events reported due to false detection of blower motor stalls.
Acción
Phillips is advising affected facilities to discontinue use of the V60 until V2.10 s/w is installed. If no other non-invasive ventilator is available, & other methods of ventilator support are deemed inappropriate or undesirable for the patient, facilities may continue to use the V60 under the conditions below:
1. Make arrangements to have V2.10 s/w installed on affected devices ASAP.
2. To minimise risk of illness or injury, operate the V60 as defined in the operator’s manual & promptly attend to all alarms presented by the V60.
3. As recommended, use an external O2 monitor/analyser & set the alarm thresholds appropriately.
4. As recommended, ensure the correct circuits and masks identified in the operator’s manual are used with the V60.
5. Wherever possible, connect the V60 to a remote call system.
If the V60 Shuts down, alarms & displays Error Code 100E, turn the V60 off & restart the ventilator. If 100E occurs again, discontinue use of the V60 and use an alternate ventilator
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, greatbatch medical has received reports of a pouch seal integrity issue with a specific lot of mobicath bi-directional guiding sheath. one side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. the use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
Acción
JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM 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
An issue has been identified that in rare cases, the meducore easy battery pack may fail. in the event of failure, it would no longer be possible to administer a shock to the patient, which could lead to unsuccessful resuscitation.
Acción
USL Medical will be providing users with a replacement battery. Once the replacement battery is received, users are to immediately remove and discard the affected battery and insert the new battery into the device. Whilst waiting on the replacement battery, USL Medical recommends close monitoring of the status indicators on the front of the Meducore Easy AED to ensure battery and device readiness.
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 aerowound combine dressing is comprised of an absorbent pad enclosed in a polyester/viscose over bag. each sterile dressing is sealed in an individual pouch. it was discovered that one of the pouch edges has a weak sealing strength which could compromise the sterility of the device.
Acción
Aero Healthcare is advising customers to quarantine all affected stock within their control. Distributors are advised to forward the recall notice to retailers to whom they have sold affected products and to accept the affected stock returned to them. Distributors are further requested to contact Aero Healthcare to organise their return.
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 identified a risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table using the simtec auto field sequence option. the following issues will be addressed in the software update solution "auto field sequence (afs) motion protection”:- risk of collision due to automatic gantry movements in case of lateral table shifts and- unwanted automatic gantry movements in case of table configuration set to “manually” and the movement order to be “table first”.
Acción
Siemens is advising affected users to be aware of the updated software solution “Auto Field Sequence (AFS) Motion Protection” which will be implemented at the Control Console of their Digital Linear Accelerator. This software will not execute a movement if a potential collision is anticipated and that users may, in such cases, perform the planned movement manually. Users are further advised that despite these safety measures, there might be scenarios which are not covered by the software. Therefore, during an auto-sequence delivery, users must be aware, at all times, of any movement of the gantry, the treatment table and the applied table offsets or overrides according to the treatment plan.
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
Boston scientific has received higher than anticipated number of reports of early pin release prior to locking the valve in the final position. if this occurs, the valve is unable to be fully locked, which requires the valve to be re-sheathed and removed from the patient prolonging the procedure. removal of the valve was successful in all but one case where the valve embolised and was secured in the descending aorta. all patients were successfully treated with another valve, except for one reported case where the affected valve was removed, but an aortic dissection occurred during implantation of the second valve whereby the patient subsequently died.Please note that there are no safety concerns for patients who have previously received a lotus valve and the issue does not impact the performance of the implanted valve. it is only a potential issue during the implant procedure itself.
Acción
Boston Scientific (BSC) is advising users to immediately discontinue use of and segregate affected products. Users are further advised to immediately remove all affected products from their inventory and quarantine the affected stock in a secure location prior to their return to BSC.
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
Conmed has identified that accessory packages contained within the hyfrecator 2000 carton were packaged in error by the manufacturer, with non-sterile handpiece sheaths (ref. 7-796-19) packaged in pouches that were labelled “sterile”. this could cause an end user to use a non-sterile sheath as if it were sterile. conmed has not received any reports that this mislabelling has resulted in injury or illness. only sheaths supplied in the original accessory package of affected hyfrecator cartons are mis-labelled.
Acción
ConMed is advising customers who have an affected Hyfrecator 2000 still in its original sealed carton (unopened) to return the product to ConMed for replacement. Customers who have an out-of-carton (opened) Hyfrecator 2000 are to check if they have any remaining sheaths (Ref. 70796-19) of the affected lots and to return unused affected sheaths 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
An issue has been identified where the etco2 reading on the lifepak 15 can intermittently show a value of “xxx” after start-up or during device operation. an investigation by the manufacturer of the etco2 module has revealed that compressed air may have contaminated filters within in the module. as a result of this filter contamination, the etco2 display on the device will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation the etco2 monitoring functionality will no longer be available.
Acción
Physio-Control is advising users who experience the “XXX” after power-up or during device operation to make immediate contact to arrange for servicing of the affected device. Users are further advised that if the issue does not occur, to continue performing the daily device self-tests as indicated in the Operating Instructions and the device is safe to 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
Specific stratamr adjustable valves & shunts may experience a condition which may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (csf). the condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance. this higher than intended flow resistance is a result of the mri resistance key on the bottom of the valve’s rotor mechanism being placed on top of one of the mri resistance walls, instead of in one of the pressure setting wells. the incorrect valve rotor orientation can be caused by misalignment and/or off-center positioning of the stratamr locator tool, relative to the valve mechanism during the valve adjustment process. this condition may result in headaches, nausea, vomiting and lethargy. if left untreated underdrainage has the potential to lead to coma and death. to date, there have been no reports of death.
Acción
Customers are advised to discard and return any unused units to Medtronic. For products that have been implanted in patients, clinicians are reminded that for continued patient care that it is critical to properly align and center the Locator Tool over the valve mechanism to ensure that the valve is set at the desired pressure. Instructions that will aid in proper technique are included in the Instructions for Use and reiterated in the customer letter.
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
Smith & nephew has received a small number of complaints reporting cracks in the welds located on the head of the mallet, which is filled with lead beads. in the reported cases some of the lead beads and particles escaped from the mallet into the surgical wound. as these failures occurred intra-operatively and appropriate actions were taken to remove the lead beads from the wound during surgery, no further adverse effects were reported. smith & nephew is recalling the mallets as the risk of lead escaping from the mallet and the potential adverse effects associated with lead exposure were previously unidentified risks. based on the low occurrence (0.03%) of the worst case failure mode defined above and the high detectability should any lead beads escape into the surgical wound, no proactive follow-up is recommended.
Acción
Smith & Nephew are advising customers to immediately locate and quarantine affected devices. Smith & Nephew will arrange for the return of the devices and the provision of unaffected replacement mallets.
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
Ortho clinical diagnostics (ortho) has identified the potential for biased results generated using vitros vanc reagent. this can occur after the reagent packs are loaded onto the analyser and stored within the on-analyser stability date. some customers observed a positive drift of >2 standard deviation (sd) in quality control results when using vitros tdm performance verifiers (levels i, ii & iii). ortho's testing confirmed a positive drift in patient and quality control results within a reagent pack in as few as approximately 7 hours. for the affected lots, results may begin to show a drift as soon as packs are loaded onto the system. the magnitude of positive drift for the affected reagent packs is approximately 8-15% across the vanc reportable measuring range of 5.00–50.00 ìg/ml (3.35–33.50 (ìmol/l).
Acción
Users are advised to immediately discontinue using and discard all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. Discuss any concerns users may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action.
If users do not have an alternate lot in their inventory and have an urgent need to continue testing Vancomycin, they are advised to use the current lot provided that they perform quality control testing with every sample batch (i.e., 1 or more patient samples). Ortho recommends the following:
- Run QC fluids prior to and following each sample batch. (Use a minimum of one control fluid at the beginning and end of each sample batch)
- Ensure QC results are within acceptable limits prior to releasing sample results until replacement product arrives.
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 artis systems with a100g generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. when the failure occurs, the system usually responds by providing emergency fluoroscopy. in the worst case, a spontaneous failure of the radiation generation function is conceivable. in the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system.
Acción
Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.
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
Johnson & johnson medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. the presence of a screwdriver, (part number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. the combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. it is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. the resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated.
Acción
Customers are advised to quarantine and return the affected stock in their possession 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
Icu medical has identified a potential for detachment or separation of pressure tubing/luer bonded connections on specific blood pressure tranducer sets. icu medical has received reports due to this issue and there is the potential for serious injury. as a precaution, icu medical is recalling the affected devices.
Acción
ICU Medical is advising users to inspect stock and quarantine all affected units. Any remaining affected stock will be returned and replaced or a credit note issued.
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, immucor has identified issues with panocell-20 and capture-r ready-id.For panocell-20, donor e1011 was listed as v+ (positive) on the master list supplied with this product. the donor has subsequently been tested as v - (negative). since donor e1011 is v–, cell number 11 will be nonreactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system. for capture-r ready-id, donor d1741 was listed as v+ (positive) on the master list supplied with this product. dna testing of this donor has confirmed the donor as v - (negative). since donor d1741 is v–, cell number 4 will be non-reactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system.
Acción
Seqirus is providing revised master lists for the affected products which correctly identify the donors as V- (negative). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 05/07/2017.
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
Medtronic have identified that a specific subset of endurant/ endurant ii bifurcated stent graft systems have greater susceptibility to permeability variations associated with endoleaks identified during the initial implant procedure. at the time of implant procedure, in the event of an endoleak, this potential permeability variation in the affected subset of stent grafts may cause the physician to categorise a type iv endoleak (which typically self-resolves over time) as an acute type iii fabric endoleak because the leak may appear to be focal or a localised leak as opposed to a diffused leak (blush). this potential misclassification of a type iv endoleak as an acute type iii fabric endoleak may lead to unnecessary secondary interventions to treat the perceived acute type iii endoleak, whereas it could be a type iv endoleak that self-resolves over time. this potential permeability variation observation is limited to a subset of 23mm and 25 mm devices.
Acción
Users are advised to identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in their inventory. Medtronic is also advising that there are no actions required for patients already implanted, as the potential for endoleak misclassification due to permeability variation occurs acutely at implant. Patients who have been implanted with an Endurant /Endurant II 23mm or 25mm Bifurcated Stent Graft System affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with the standard practice.
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
A labelling error has been identified with a single lot of sealapex xpress. the product’s syringe label correctly identifies the expiration date as 2016-11. some carton labels incorrectly identify the expiration date as 2017-11. product used past the correct expiration date of 2016-11 may not perform as intended. such product may exhibit crystals in the catalyst paste.
Acción
Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.
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
Based on complaints, carl zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (ups)-module. it was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the ups at the rear side of the machine. there were no patient involvement and no adverse consequences associated with these complaints.
Acción
The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.
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
Reports have been received that some customers have experienced a higher number of invalid results than would typically be expected when using the xpert ct/ng assay and its intended use specimen types. this could lead to the need to retest and consequently, a delay in test results and subsequent treatment.
Acción
Cepheid is advising users to discontinue use and discard affected stock in their inventory. Users are further advised to acknowledge receipt of the recall letter and return it to Cepheid customer service in order to receive 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
There is a labelling issue with specific lots of the lipiflow system activator. the activator package label, box label, package insert and the lipiflow system instructions for use (ifu) specify 10°c to 40°c for the activator storage temperature. this specification was with the intent that the activator would be stored in a temperature-controlled room environment (with heat and air conditioning) with allowance for occasional fluctuations between 10°c and 40°c.Upon review, it has been determined that the labelled storage temperature should be consistent with the temperature conditions tested for the entire duration of the product shelf-life. accordingly, the storage temperature on the activator package and box labels has been revised to specify, “store at controlled room temperature.” the revised package insert and the lipiflow system ifu specify: “store the activator at controlled room temperature (20°c to 25°c) with short-term (< 72 hours) excursions permitted between 5°c and 38°c.”.
Acción
Emergo is requesting customers to read the enclosed "Summary of Important Labelling Changes for the LipiFlow System" and discontinue use of stock that are not in temperature-controlled environments (without heat and air conditioning). Customers are further requested to contact their local distributor to organise for replacement stock. This action has been closed-out on 23/06/2017.
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
A recent testing of liaison c-peptid assay by diasorin has highlighted the issue of cross reactivity with human proinsulin. this cross reactivity occurs in 100% of the tested samples and results in an increased c-peptide concentration in all samples tested, across all populations. for normal patients, the risk of falsely elevated results is rare, since the concentration of proinsulin in healthy fasting people is at least 100 times lower than the c-peptide concentration and therefore has only minimal effect on the results determined with the assay. patient populations of highest risk for falsely apparently elevated assay results are patients with insulin processing defects, renal malfunction, insulinoma or similar conditions.
Acción
DiaSorin is requesting users to confirm receipt of the “Urgent Recall for Product Correction” notification by completing the response section and returning it to DiaSorin. Users are advised of the possibility of further action pending TGA's receipt of additional information.