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 detector braking systems may be rendered ineffective resulting in one or both detectors moving to their mechanical limit. in the case of this kind of failure, the detector motion cannot be halted using normal operator intervention (e-stop, collimator contact sensor activation). the detector(s) may move down onto the patient or operator, potentially resulting in entrapment and/or serious injury or death. any brightview, brightview x or brightview xct where components on the braking system have been serviced is potentially affected. systems that were serviced and received a complete brake assembly are not affected by this issue.
Acción
Customers are advised to immediately discontinue use of the system until Philips Service has undertaken the inspection of the system. The system can be returned for clinical use if the system brakes pass inspection. If the system brakes fail inspection, the system will be returned for clinical use once the correction is implemented.
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
Cook medical is instigating a change in the intended use wording of the product instructions for use (ifu). this change is in response to the report of two potential adverse events during use in urological or gynecological procedures. this change will provide clarification of the product's intended use, with the addition of the following statement in the ifu: "this device is not intended for use in urological or gynaecological procedures".
Acción
Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update.
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
Software anomalies have been discovered in the vidas 3 software version 1.1.4. the following are the limitations that could impact the system:1. the “error code 0550capu1” posted in case of tip lost does not suggest the appropriate troubleshooting 2. for customers using automatic pipetting mode: non-justified “error code 0400fapu1”3. stop section during analytical phase can induce drop on the strip or into the instrument4. for customers managing their internal/external quality control via quality control module of vidas 3 only5. for countries applying winter time change only.
Acción
bioMérieux is advising users to apply the required actions associated with the relevant limitation (as described in the customer letter). Users are further advised to discuss concerns about previously reported results with their 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
Randox has confirmed a change in recovery with regards to myoglobin in the lots of the liquid cardiac control listed above for the randox immunoturbidimetric method. internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method. recovery of myoglobin for other methods quoted in the ifu has not been confirmed. customers using methods other than the randox immunoturbidimetric method should review their running iqc mean for a shift in trend which may indicate a review of the control range is required.Iqc that is reported as out of range could lead to a delay in reporting myoglobin results. since serum myoglobin is not typically used in isolation for diagnosing cardiac injury a delay in reporting these results should not pose a serious risk to health.
Acción
Users are notified to remove the existing IFU from all unused stock and replace it with the lot specific document provided with the customer letter. Also, users are advised to discuss the contents of customer letter with their Medical Director and review results generated with the affected batches in line with the clinical profile of the patient.
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
There has been confirmation that in isolated cases when enzymatic creatinine (ecrea) is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ecrea result. whilst it is understood that users routinely run quality control (qc) after system maintenance, it is particularly important to run ecrea qc after the probe test to identify a potentially elevated ecrea result. (please note that this information applies only to laboratories processing enzymatic creatinine (ecrea: enzymatic creatinine cat no. k1270a, smn 10700444) after the implementation of the automated acid clean (acln) maintenance routine).
Acción
Siemens is recommending affected users to adhere to the following steps:
1) replace the appropriate reagent probe (only if the ECREA reagent probe has not been replaced since the activation of ACLN)
2) process QC which includes ECREA immediately after routinely scheduled Off Peak Activities including Probe Test; and
3) contact Siemens Customer Care Centre IF, after replacement of reagent probe, users experience elevated ECREA QC results directly after Off Peak Activities which includes the Probe Test or after manually processing the Probe Test.
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 of instrument malfunctions for phadia 250 due to deformed bottles in the above-mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument, which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim, located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results, mainly a false positive, with regard to all elia assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message “3-145 right arm liquid detection below lower limit with target 2”.
Acción
Users are notified to stop using the affected lots and record the lot numbers and quantity of any unused products prior to discarding them. Abacus ALS will organise replacements at no charge. Also, users are advised to discuss the contents of the letter with the Medical Director to ascertain if any further actions are 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
In september 2014, siemens healthcare diagnostics issued customer notification dc 14-09 that addressed a high rate of “abnormal assay” test report messages for its dimension ammonia (amm) assay. internal testing revealed that the “result monitor below” mean factor for ammonia (ammdf119) is set with a narrow limit, which may cause some ammonia results to be inappropriately flagged with an “abnormal assay”. flagged amm “abnormal assay” results may be attributed to a contamination of open wells of the amm flex reagent cartridge. quality control (qc) and patient samples may be affected; however, affected results are appropriately flagged.
Acción
Siemens is reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM IFU revision E will reflect this change.
The new version of Dimension software, 10.2, will do the following:
- Automatically move to a new well every day. This decrease in the open well maximum duration reduces the amount of time the AMM reagent is exposed to any potential contaminates, reduces the need for customers to manually move to a new reagent well, and aids in the prevention of erroneous flagging.
- Contain the Below Mean Factor limit of 0.90.
Users are notified that until Dimension 10.2 software is installed on their instruments, manually move to a fresh AMM well of reagent every day. Also, to reduce the likelihood of false AMM “Abnormal assay” messages, verify that the Below Mean Factor for the Result Monitor is set to the revised limit of 0.90 by following instructions provided 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
The manufacturer has received six reports where an open seal of the immediate packaging of devices was identified by customers. this open seal has the potential to compromise the sterility of the device(s). to date, no reports have been received in australia.The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device. the issue of the packaging failure is visually obvious.
Acción
Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.
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
The vitek ms system could give, in specific conditions, an incorrect identification result if the tested species is not included in the vitek ms knowledge base (kb). when the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. consequently, the system can give:1) no identification when the spectrum acquired does not match with any species pattern.2) a low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.3) an incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.This is a system limitation with all maldi-tof databases which is currently not described in the user manual.
Acción
Biomerieux is advising users to take the limitation (as detailed in the recall notification letter) into account when using the device.
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 the sterile packaging of the covidien curity eye pad, curity eye pad oval and curity sodium chloride dressing to be compromised. hence, the use of products with this issue may result in an increased risk of infection. to date, there have been no reports of infection associated with this issue.
Acción
Medtronic is advising customers to quarantine and discontinue the use of affected stock. Customers are also requested to label the stock with the provided ZRE # (number) prior to their return to Medtronic whereby customers will receive credit to the value of the returned 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
Heartware has developed an updated heartware hvad system controller following two previously communicated urgent field safety notices that occurred in april 2015 and april 2016. with the introduction of the updated hvad controller, also referred to as controller 2.0, heartware is initiating removal procedures for previous generation heartware hvad controllers with serial numbers lower than con300000, and all heartware dc adapters, product code 1435 (all serial numbers), which are incompatible with the new hvad controller. the removal of these hvad controllers and dc adapters will occur concurrently with the introduction of the new hvad controller.The new hvad controller includes enhancements to address the potential safety issues identified in april 2015 and 2016.
Acción
1. Review the HeartWare supplied notice/forms, & forward the notice to individuals who need to be aware of its contents.
2. Complete, sign & return the supplied Acknowledgement Form to HeartWare.
3. Complete training that will be scheduled & conducted by HeartWare, which is required before new HVAD Controllers will be distributed. Patients must be educated on using the new HVAD Controller by hospital staff who have received training from HeartWare. Do not exchange current HVAD Controllers and DC Adapters until after this training.
4. Quarantine & replace affected HVAD Controllers, DC Adapters, IFUs, Emergency Responder Guides & Patient Manuals in hospital inventory after training is complete.
5. Notify and schedule an appointment for each patient ASAP to exchange their controllers.
6. Return all quarantined HVAD Controllers & DC Adapters to HeartWare.
7. Once affected product has been identified and returned, complete & return the supplied Completion Form to HeartWare.
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 confirmed that some lots of vitros nt-probnp reagent packs exhibited the potential for an increased frequency of calibration failures, with an unexpected increase in signal for the level 1 calibrator, potentially causing a failure of the calibration parameters. preliminary testing has indicated that the calibration failure is related to a component of the vitros nt-probnp reagent pack and is not associated with the vitros nt-probnp calibrators. please note that investigations have confirmed that the increase in signal does not affect sample results (i.E., quality control or patient samples) within the 28 day calibration cycle.
Acción
Ortho Clinical Diagnostics (Ortho) is advising users that they will be sent the revised Master Calibration data to ensure successful future calibrations. In the interim, users are requested to refer to the workaround details contained in their recall notifications. Users (of Lots 1580, 1590 and 1620) who experience this issue and who no longer wish to use the affected products can have the option of having their accounts credited for the product/s discarded.
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
There has been an increase in reports of blood loss associated with devices using a specific haemostatic valve design (referred to as the “blue” valve or polyisoprene valve). in november 2015, products manufactured with the haemostatic blue valve design were either made obsolete or changed to incorporate a different valve design with improved haemostasis. cook has continued to receive reports of blood loss associated with the earlier generation products containing the “blue” valve and therefore has initiated this action on those devices. potential adverse events that may occur if these devices are used in the arterial system include delay in procedure and blood loss. if devices are used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism.
Acción
Customers are notified to quarantine and immediately return any affected product that remains unused 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
There has been an increase in reports that the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder and ureter. potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
Acción
Customers are advised to quarantine and immediately return any affected product that remains unused 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
Inova pharmaceuticals (australia) pty ltd (inova) is conducting an urgent recall of 82 lots of 11 laseredge knife skus used in ophthalmic surgery due to an atypical number of dull blade complaints. if excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.Patients undergoing posterior segment surgery (e.G. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. the likelihood of adverse events associated with dull blades is very low.
Acción
Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.
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 the sysmex haematology analyser xn-series may generate an intermittent inaccurate low eosinophil count. patient samples analysed by the xn-series analyser reported 0% eosinophils count, but on subsequent manual review, up to 11% eosinophils were observed. this issue may lead to misdiagnosis or delay in treatment for conditions such as allergies or parasitic infections.
Acción
In order to detect the phenomenon, Roche is recommending users set up an Action comment or a Block Validate rule in the Rerun/Reflex/Comment Rule in the IPU settings when certain conditions are met. Users are advised that this action is currently undergoing validation and upon finalisation, a followup notification will be communicated to them. Users are also requested to discuss this matter with their Medical Director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
As a precaution, arrow international has initiated a recall for this product because these finished good kits may potentially contain an incorrect component. this issue came to light through an internal inspection. a 4fr single lumen catheter was found in a 5fr double lumen kit. through investigation at the manufacturing facility it was determined that there is a potential that the reverse scenario could also have occurred, 5fr double lumen catheter ending up in a 4fr kit thus both product codes/lots are in scope of the action. zero complaints have been received for this issue (either scenario) furthermore no product has been found internally for 5fr catheter in a 4fr kit.
Acción
Teleflex is requesting that customers:
1. Provide the customer letter to all who need to be aware of it within their organisation.
2. Inspect any stock on hand. The kit tray is transparent & does not need to be opened to determine the type of included catheter.
3. Lift the non-sterile pouch with the product information up to identify if the catheter has a single or double lumen.
4. Once all stock has been inspected, complete the Acknowledgement Form supplied with the customer letter with the details obtained during inspection. Note - include details of all stock implicated in this issue.
5. Return the completed & signed form to austcs@teleflex.com by 1 September 2017. If stock contains a 4FR Single lumen catheter – there is no impact and the stock can be used as normal. If stock contains a 5FR Double lumen catheter – this stock is impacted. In the event you have impacted stock a customer service team member will be in contact with you to arrange collection of the goods.
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 determined that a circuit board that controls motor functions in specific instrument systems can affect device positioning on the pipettor and incubator belt while the instrument is running. users may experience the following errors that may cause a delay in the reporting of patient results: - an incubator belt motion error which can result in the instrument going into the not ready mode and cancellation of all in-process tests; and/or - z pipettor motion errors which can result in cancelled tests.In the worst case scenario, the potential harm would be a delay in patient diagnosis and/or treatment, with a potential worst case severity of permanent injury. the probability of harm for this event is unlikely.
Acción
Beckman Coulter (BC) is advising users to adhere to the following interim instructions. If you experience:
- z pipettor motion errors, to re-run any cancelled tests; and/or
- incubator belt motion errors.
please review the associated event on the ‘Event Log’ screen and follow the troubleshooting instructions provided. Users are further advised that they will be contacted by their BC service representative to schedule a visit to replace the circuit board on their instruments as a permanent fix.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An issue has been identified where a retrospective respiratory gated 4d ct scan is performed with the bellows pulmonary gating device, the ct images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). this may lead to a couple of scenarios that may result in misrepresentation of the 4d ct images with a respiratory gated 4d ct scan and reconstruction. in the event this occurs a misrepresentation of ct images may result, due to the incorrect image pulmonary phase annotation or the need to rescan the patient due to an incorrect image pulmonary phase.
Acción
Philips is recommending users to follow the instructions as outlined in the recall notification letter. The letter contains information to prevent the occurrence of the scenarios as well as the corrective actions to take when they do occur.
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 whereby the insulation of an electrode has been damaged intra-operatively when it is pulled out of the minop invent trocar. subsequent investigation has shown some burrs at the distal working end of the trocar.
Acción
B. Braun is advising customers to complete and return the Reply Form in order for their affected stock to be collected and 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
An issue regarding the reformatter modules urf and brf of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. this issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. sample spillage may cause cross contamination of samples and potentially expose operators to infectious material.
Acción
Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation.
This action has been closed-out on 15/03/2018.
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.