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
Becton dickinson (bd) has identified a software anomaly with the alaris syringe module, model 8110; software version 9.15. this anomaly may cause a small percentage of syringe infusions to unexpectedly stop when an infusion is transitioning from one state to another. infusion transitions that may be impacted by the failure are: - a complete bolus transitioning to a continuous infusion - a basic, continuous or intermittent infusion transitioning to near end of infusion (neoi) state - a basic, continuous or intermittent infusion transitioning to a keep the vein open (kvo) state the error code will cause an audible and visual alarm on the alaris pc unit and scroll a channel error message on the alaris syringe module. becton dickinson is not aware of any report of injury attributed to this defect.
Acción
BD will arrange for a product correction (i.e. software upgrade) to mitigate the issues. In the interim, users are advised that if error code 351.6610 occurs, the user can clear the channel error by pressing “CONFIRM”. After the channel error is cleared on the PC unit, the user can detach and re-attach the module to restart the infusion, or power off the PC unit and then power back on to restart a new infusion. The user should replace the affected Syringe module as soon as possible and isolate the Alaris Syringe module that exhibits the channel error code.
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 storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°c for longer than 14 days. as a result, the shelf life of the test strips may be affected. use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required.
Acción
Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature.
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
The manufacturer has received reports of air-in-line (ail) alarms that have occurred when no air is observed in the line. while the pump is infusing, the system may indicate that an ail alarm has occurred when no air is in the line. in some cases, these false ail alarms may be attributed to a faulty ail sensor.To date, bd is not aware of any report of injury attributed to this defect in australia.
Acción
If AIL alarm occurs, the user should do the following:
1. Determine if there is air visible in the tubing that has caused the alarm. If there is air visible in the line, clinician can evaluate whether or not it is clinically significant and remove it according to hospital protocol, if necessary.
2. If no air is observed, ensure that tubing is properly installed in AIL Detector. False AIL alarms may occur if tubing is not properly installed. When inserting the tubing into the AIL detector, use a fingertip and firmly push the tubing toward the back of the AIL detector.
3. If AIL alarms continue to reoccur on the same pump, after air has been removed from the line and tubing has been properly loaded, the AIL sensor may be faulty. If the AIL sensor needs to be replaced, BD will provide replacement parts at no charge. If a pump has been identified as having recurring AIL alarms without evidence of air in the line, then replace the AIL sensor with a new AIL sensor provided by BD.
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
Following a customer complaint and an internal investigation, biomérieux has confirmed that when testing weak viral load samples, in conjunction with bk virus r-gene kit on smartcycler 2.0 platform, negative results may be obtained instead of positive as expected. the investigation confirmed that the issue has been observed only with smartcycler 2.0 and the issue only concerns low viral load samples (viral load equal or below the sensitivity control). the issue is detected by the sensitivity control (sc) that is the equivalent of a weak positive sample, which will be systematically negative instead of positive in most of the cases. when no sensitivity control is systematically run, there is a potential risk to obtain a false negative result. based on the investigation data, the performances claimed in the ifu regarding the use of smartcycler 2.0 in conjunction with bk virus r-gene kit could not be warranted.
Acción
bioMérieux is advising customers to stop using the BK Virus R-gene kit ref. 69-013B on Smart Cycler 2.0. It is recommended that any concern customers have regarding previously reported results is discussed with the Laboratory Medical Director to determine the appropriate course of action.
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 problem has identified a problem with the diego elite tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. if the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. at this stage, no reports of injuries relating to the drive shaft disengagement have been received.
Acción
Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or 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
The manufacturer, lemaitre vascular has identified that the box labels for certain lots of catalogue numbers 4012-02 and 4012-03 have an incorrect dimension listed. the box label for each size device illustrates a clip gap that is smaller by 0.3mm – 0.5mm than the actual clip of each size product. the ifu and tyvek labels for the product have the correct size of the clip gap noted for each size. there have been no complaints about this issue.
Acción
Emergo is advising customers that all affected product should be returned for replacement. This action has been closed-out on 06/07/2017.
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
Occlutech has received a report whereby a customer inadvertently used an expired occlutech flex ii pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other, it is important to check both dates to not miss the shortest expiration date.
Acción
Occlutech will in future be implementing a revised Occlutech product set label showing only the shortest expiry date. For current inventory, Getz Healthcare is advising customers to immediately check the expiration dates of the Occlutech Occluder and of the pusher cable as printed on the outer box-label of all products in their current inventory. If one of the expiration dates is exceeded, customers are to block and remove the Occlutech Occluder set containing the expired product from their inventory. Getz will replace all expired stock. End-users are also advised to carefully routinely review the Occutech Occluder set labels prior to use, in accordance the Instructions for Use.
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
The identified products may have a rare condition related to the strata valve that can lead to an inaccurate pressure level (pl) reading on the strata indicator tool or stratavarius system. the condition occurs when the magnet inside the valve becomes reverse polarised, which may occur only if a patient has been exposed to 3t mri magnetic field or greater, and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. medtronic's investigation identifies that a reverse-polarity magnet has a relatively small chance of occurrence (rate: 0.007% over a two year period). over the two year period, a total of five complaints received included three adverse events (three revision surgeries). however, only one revision surgery was confirmed to occur due to the reported product problem. there have been no reports of other instances of disease, illness, or injury.
Acción
Clinicians are advised that the expected adverse health consequences are the same as those experienced during the course of hydrocephalus management (eg. headaches, lethargy, nausea, vomiting), or those related to a revision surgery).The IFU for the products is being updated to include the following verbiage to reinforce the warnings/precautions:
“Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism damage if exposed to 3.0 tesla MRI. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The reading from the Strata II Indicator tool or StrataVarius system may be reversed (180 degrees opposite) from the radiographic image. In this situation, radiographic imaging should be used to determine the setting of the valve.”
For further information, please refer to:
https://www.tga.gov.au/alert/medtronic-strata-ii-strata-nsc-valves .
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
Roche diagnostics australia has received several reports that lysercell wdf 2 x 4l lots a6028, a6029 and a6030 can lead to an increased occurrence (up to 3-fold) of the flag “blast/abn lympho?” . no other flags have been observed. this issue leads to an increase in the “blast/abn lympho?” flagging rate and unnecessary manual review. the risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
Acción
Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.
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 software issue affecting some minimed 640g insulin infusion pumps that could prevent the internal battery from charging has been identified. should this issue occur, an alarm will be triggered and users will see a "power error detected" message accompanied by the number “25”, displayed on the pump screen. users are advised not to ignore this alarm and error message, which means that their pump has now stopped delivering insulin. if not, users could develop high blood sugar levels (hyperglycaemia).
Acción
Medtronic has contacted users who could potentially be affected and relevant health professionals to provide further information about this issue. Medtronic is advising users who experience this error to phone the Medtronic 24 hour Helpline (1800 777 808 - option 1). Users will be guided to troubleshoot to determine the cause of the error message and to perform a pump reset process which will reset the condition that caused the software anomaly. If the error cannot be corrected, the pump will be replaced.
TGA will soon be publishing a web statement about this 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
Siemens have identified that incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide. this can happen if the slide, on which the sensors used to detect the rotational collimator position are mounted, is not in its fully latched position. if the user is not aware of the incorrect values the patient can be mistreated by dose at the wrong location.Siemens were also made aware of a defective weld seam at overhead suspensions. due to such a defect the weld seam might break and the overhead suspension might fall down. this can lead to a severe injury of the patient or any other person.
Acción
Siemens is undertaking hardware updates regarding the collimator position detection and improper weld seam at overhead suspensions.
To keep the sensor slide in its latched position, a locking plate will be mounted to the sensor slide. This will significantly reduce the risk that the sensor slide might be mechanically misaligned and cause incorrect values being displayed for the rotational collimator position.
As reinforcement, a bracket will be added to the overhead suspension to ensure the stability of the connection. This will prevent the overhead suspension from falling down.
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
Abc1 hla typing trays included in a single lot of acb1/acb2 kits contain a manufacturing defect that can result in false positive or false negative results.
Acción
Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 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
The manufacturer, iris international, has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. the greatest impact could occur when proteinuria is not detected. a control failure could indicate inadequate dosing caused by probe bending/misalignment that occurred due to probe mishandling during maintenance or troubleshooting, or through use of an incorrect tube type or placement on the system.
Acción
The manufacturer has designed a Pipette Mounting Block that will better secure the probe, avoiding misalignment and bending. A Beckman Coulter representative will contact customers to schedule a service visit for implementation.
In the interim, the following actions are recommended:
- Avoid bumping the probe during maintenance or troubleshooting.
- Carefully follow instructions in your Operator’s Manual, PN 301-7146 or 300-4449, for utilising the Pipette Safety Parking Device, using the approved tube types, and removing tube caps before sample analysis to avoid probe-tube collisions.
- Perform a patient cross check or run quality control after performing maintenance or troubleshooting in the probe area. If there are concerns with the results, contact Beckman Coulter.
- Consult with the Laboratory Director to determine whether a retrospective review of results is clinically warranted.
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
Dräger became aware that the battery capacity of the optional ps500 power supply unit was unexpectedly reduced. this resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. the reported issue may cause unexpected loss of automatic ventilation functionality.Further to the recall for product correction in feb 2016 (tga ref.: rc-2016-rn-00154-1), dräger has now developed device modifications to rectify the issue.
Acción
The device modifications include the following:
- Installation of a new software 2.50 with improved battery charge management
- Improved charge management for external batteries
- Option of performing a battery check to determine the battery's current runtime
- Option of displaying the remaining battery capacity in minutes
- Installation of an additional internal backup battery
- Replacement of the power supply unit to support both the external battery and an additional internal battery
- Replacement of the existing external batteries.
The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.
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 detected that when the brainlab offset cup impactor universal (blue handle) is reprocessed in a sterilisation tray as described in the current brainlab cleaning, disinfection and sterilisation guide (revision 5.2 and previous versions), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 can only be achieved if the device is individually wrapped for sterilisation. if a non-sterile brainlab offset cup impactor universal (blue handle) is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to an infection. at this stage, there have been no reports of affected patients due to this issue.
Acción
Brainlab is advising users to follow the sterilisation instructions in the current version (BL-IL-60960-69ML Rev. 1) of the IFU. Users are reminded that in addition to following the other instructions in the IFU, the Offset Cup Impactor Universal (blue handle) must be sterilized in an individually wrapped configuration.
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 regarding the angiojet ultra 5000a console foot switch sticking during use resulting in an undesired continued operation of the device. this situation can occur as a result of the wear and tear of the foot switch, which is normally captured through routine servicing. the most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. at this stage, there have been no reported patient adverse events as a result of these complaints.
Acción
Users are advised that if the situation occurs during use, perform the troubleshooting steps per the operator’s manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. Boston Scientific is advising users who have this issue to discontinue use of the AngioJet Ultra 5000A Console foot switch and to contact their local sales representative. No action is required by users whose device is operating correctly.
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
Biomérieux have found that the current shelf-life claims of multiple etest products are not supported by internal testing. there is potential to obtain a mic result that is higher than expected after 24 months for fm1024 (b) ww, after 48 months for gm256 (f) ww and tm256 (f) ww, and after 12 months for the remainder of the affected products. this type of error would be detectable during qc testing as an out of range mic result would be obtained. patient results may also be elevated resulting in a false resistant result. accordingly, the shelf-life claims have been revised to 24, 48 and 12 months, as appropriate. when used within the revised shelf-life, the products will continue to perform per the labelled performance specifications.For etest ceftriaxone products there is also a potential performance issue on strain categorisation for streptococcus pneumoniae strains when using the 2016 clsi or 2016 eucast guidelines. there is potential to obtain a false susceptible result.
Acción
bioMérieux is advising customers to identify impacted lots of the ETEST products and take note of the new expiry dates. Customers are to discontinue using and discard the expired lots. Credit will be provided for expired product. Lots that have remaining shelf life can continue to be used.
For ETEST Ceftriaxone TXL32 SPB WW lots that may have a strain categorisation issue, laboratories can continue to use the ETEST if they apply the recommendations provided in the customer letter. ETEST Ceftriaxone TXL32 (F) WW has been discontinued and customers can transition to ETEST Ceftriaxone TXL32 SPB WW.
It is recommended that customers consider retrospective analysis of patient results.
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
Roche have determined that the performance of the elecsys anti-hav assay is affected by certain types of plasma specimens. when li-heparin and na-heparin plasma specimens were compared to serum samples during internal investigations, the specified required recovery could not be achieved. values were found to be on average up to 35 % below those obtained in serum. this under-recovery may occur across the entire measuring range. a false negative result may occur only where heparin plasma samples are within close proximity to the medical decision point of the assay at 20 iu/l. in all other cases, interpretation of the results would be unchanged. based on these findings, li- and na-heparin plasma specimens will no longer be claimed to be acceptable specimen types in the ifu. in addition, for k3-edta & citrate plasma specimens, the specified criterion in the ifu that the recovery compared to serum specimens has to be within 90-110 % has been broadened to 80-120 %.
Acción
The Elecsys Anti-HAV IFU will be updated to remove Li-heparin or Na-heparin plasma as acceptable specimen types and to include the following limitation: For plasma treated with lithium heparin or sodium heparin, the values found were up to 35 % lower than those obtained in serum. In addition, for the acceptable specimen types K3-EDTA and sodium citrate plasma, the criterion for mean recovery will be updated to 80-120 % of serum value.
Users are advised to take note of the updated limitations and not use Li-heparin or Na-heparin plasma specimens with the assay. Laboratories should also consider retesting in accordance with relevant clinical information, if they suspect discrepant results with Li- and Na-heparin plasma specimens or have specific questions.
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 that the immulite 2000/immulite 2000 xpi sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with specific reagent lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use. reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots affected can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. this issue does not impact the immulite/immulite1000 platforms.
Acción
Siemens is advising that reconstituted adjustor lots 124 and 125 are to be stored at 2-8°C or -20°C for up to 14 days, after which they must be discarded. Based on the recommended calibration interval, this allows two calibration events at day 1 and 14 after opening the SHBG reagent kit. Replacement product can be requested from Siemens if adjustors available in the laboratory are not sufficient to utilise the full reagent kit. The customer letter should be reviewed by the laboratory Medical Director and review of previously generated results is at the discretion of the laboratory.
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
Olympus is extending the previous recall for product correction (tga ref.: rc-2015-rn-01141-1) from selected serial numbers to all serial numbers in the market. endoeye distal end can under certain circumstances become hot if the temperature sensor at the device’s tip is damaged (a mechanical breakage of the temperature sensor). although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.As part of the previous action selected serial numbers had the fog-free function disabled due to the backup mechanism (software) designed to detect and identify the failed temperature sensor was not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. this was shortly followed by phase ii correction to replace the hardware (cable) and restore full functionality of the fog-free function.
Acción
Users are advised to discontinue the use of any affected devices in their inventory. Olympus Field Service will schedule a time for to deactivate the fog-free function on the device. The visualisation of the devices will be unaffected and they can be immediately returned to routine use following correction. Customers will be notified once Olympus has concluded the technical investigation and established the permanent solution.
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 reported incidents of a patient step detaching from the table. a fall from a patient step detaching while in use could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
Acción
GE Healthcare will correct all affected products and a GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised to check the table tub bottom pan and patient step hardware for any looseness. Discontinue use of the patient step in case of any looseness and immediately contact the GE service representative.
This action has been closed-out on 1/03/2018.
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
Multiple software issues have been identified for software versions v1.0 to v1.2. these issues may affect the operation and workflow of the advia centaur xpt system, and the potential exists for an apparent delay to testing. the issues are detailed in the customer letter and relate to the following: system status unknown, las communication, qc profiles, 'no primary' error, and lis specification.
Acción
The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.
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.