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 there is a potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. it has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. this issue affects all expired, in-date gens, and future product until further notice.
Acción
Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a 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
Siemens has confirmed that the presence of dhea-s (a metabolite of dhea, a steroid hormone that may be used as part of in vitro fertilisation (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results on certain platforms around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. this threshold is used by some ivf protocols to determine whether to proceed with fresh embryo transfer in the current cycle.
Acción
Affected assays should not be used to report results for patients who are taking DHEA supplements.
For patients taking DHEA supplements, an alternate method such as Liquid Chromatography-Mass Spectroscopy (LCMS) which is not expected to show cross reactivity to DHEA-S should be used to measure progesterone concentrations.
Siemens’ Progesterone assays may continue to be used to report results for patients who are not taking DHEA supplements.
A 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
The base of the architect cuvette segment may become detached under specific conditions. when a segment base is detached, cuvettes may be seated lower than the designed height. this may result in inadequate dispense into specific cuvettes due to the sample probe being unable to makeefficient contact with the cuvette bottom.Reasons for the bottom of the cuvette segment to detach are• excessive force applied during manual cleaning of cuvettes or cuvette wash tower crashes• lack of sufficient glue during cuvette segment manufacturing (c4000 and c8000 only)if a segment is detached, there is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the instrument. falsely depressed results may or may not be accompanied by a result flag.
Acción
Impacted patient results may be accompanied by “<” or “LOW” result flags, indicating that the result is below the linear range or the defined normal range of the assay, respectively. See ARCHITECT System Operations Manual Section 5: Operating Instructions for more information on patient result flags.
Abbott is providing users with new instructions to avoid damaging the cuvette segments.
A review of previously generated patient results is at the discretion of the Laboratory Manager,
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Radiometer has recently become aware that the abl90 flex in a very rare specific situation can aspirate calcium solution instead of rinse solution.The specific situation can occur when the following takes place:1. the analyser is in ready mode;2. operator lifts the inlet and then closes it again, thereby initiating a rinse; and3. immediately after lifts the inlet and quickly closes it again.In this situation, it will lead to several parameters reported incorrectly. some of the parameters will not have an error message or question mark indicating a problem with the result.
Acción
Radiometer are advising customers:
1. Inform users of the ABL90 FLEX analyser that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyser flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. Users may re-use the same solution pack;
2. It is recommended that users review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1 stated in the customer letter;
Radiometer will release a software solution (SW V 3.4) which corrects this issue. An updated IFU will also be provided to users upon completion of the software upgrade.
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 has received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using vitros chemistry products phbr slides. an investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Acción
End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Beckman coulter has confirmed customer reports of the affected lot failing calibration with error condition ocr low. the calibration failures appear to be related to improper shipping or storage conditions.
Acción
Beckman Coulter is requesting end users to discontinue use of the affected lot. Re-assessment of past results is not required as the LACT results produced after acceptable QC recoveries on each reagent cartridge are accurate.
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 bug has been detected in the cobas integra 800 software version 9864.C2 which affects the execution of routine maintenance of the ise module. the issue is caused by the ise counters in the software being reset to zero whenever the ise rack is removed from the analyser. lf ise service actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (slope, sol i dev etc), as well as incorrect and unflagged ise results.
Acción
Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is a potential for incorrect results to be reported when the versacell system drops a sample tube during transfer to the immulite 2000/immulite 2000 xpi automation rack under certain specific conditions. this issue only occurs with versacell systems that are connected to immulite 2000/2000xpi and does not affect any other analysers that interface with the versacell system.
Acción
Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017.
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
Siemens healthcare diagnostics has received complaints regarding variability in recovery of qc and patient results with the dimension vista csa flex reagent cartridge lots 12300bb, 12318bb, and 13011bb. investigation by siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with csa concentrations below 125 ng/ml. daily qc checks can detect performance variations in this assay.
Acción
Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a 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
Beckman coulter has confirmed that some ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected. affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
Acción
Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary.
As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve 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
Radiometer medical has become aware that some pco2 membranes can cause a negative bias, on both blood and quality control measurement results.The bias can be seen after the replacement of the membrane.
Acción
Radiometer Medical are providing additional quality control instructions to ensure the accuracy of pCO2 results. This action has been closed-out on 10/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens previously communicated an issue with low bias on patient results for dimension tacrolimus flex reagent cartridge lot fa3316 (urgent medical device recall dc 13-02a and tga ref rc-2013-rn-00050-1). siemens will be implementing linking of specific dimension tacr calibrator lots with specific dimension tacr flex lots to ensure accurate recovery and continued traceability of patient results to the lcms reference method. due to the requirement for linked calibrators, lots 2ed072 and 2kd084 can no longer be used.
Acción
Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot 2ED072 and 2KD084. To ensure the correct linkage between calibrator and reagent lots, customers are requested to contact their Siemens customer service to order lot linked combinations.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Hemocue has become aware that the hemocue glucose 201 microcuvette (lot number110718) may, at the end of their shelf-life, yield measurements higher than expected. the higher glucose values may have led to unnecessary insulin treatment or lack of glucose treatment.
Acción
The microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. It is recommended that the need for repeat testing be determined by the laboratory or clinical director. This action has been clsoed-out on 22/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This product contains detectable levels of hcv rna which originated from the non-specific human igm component used in the mouse monoclonal antibody conjugation process for this product.
Acción
Bio-Rad is asking users to destroy the affected stock using appropriate disposal methods.
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 confirmed customer complaints of low patient sample recovery with tacr flex, lot fa3316. quality control materials have not exhibited low recovery of the same magnitude.
Acción
Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot FA3316. Laboratory Directors are also being advised to review patient tests to determine if follow-up testing is required.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is the potential for vitros vapor adsorption cartridges sales unit cartons to incorrectly contain a particulate cartridge (part number j19612).
Acción
Ortho Clinical Diagnostics (OCD) is requesting end users to ensure that a VITROS Vapour Adsorption Cartridge is installed. If a Particulate Cartrtigde is installed it must be replaced immediately with the correct cartridge and reported to OCD Customer Technical Services. Results generated while a Particulate Cartridge was installed must be reviewed. Any concerns with previously reported patient results should be discussed with the laboratory 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
Siemens has identified that immulite/immulite 1000 cortisol kit demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. the positive bias was also observed in quality control materials and may result in values outside the established ranges.. the observed positive bias in cortisol values may potentially lead to additional investigation of adrenal status.
Acción
Siemens are advising users to discontinue use and discard any remaining kits. The issue has been resolved with IMMULITE/IMMULITE 1000 Cortisol kit lots 384 and above (supplied since 1 August, 2014). A look back of previously generated results is at the discretion of laboratory. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An abbott investigation has identified that the ict serum calibrator lots above may generate lower than expected potassium qc and patient results. a potential cause of this issue is increased ammonia content over the shelf life of the calibrator. elevated ammonia concentration may impact the potassium calibration and potentially cause a calibration curve to generate the lower results. patient results may have shifted down by 1-3% beyond the acceptable performance of the assay.
Acción
Abbott is advising their customers that if the calibration curve for Potassium is verified with at least two levels of controls according to established quality control requirements for the laboratory, continue to use the lot until new lots are received through the normal ordering processes. If QC results for Potassium are not within established quality control requirements, uses are advised to recalibrate using a different calibrator lot. This action has been closed-out on 03/02/2017.
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
Investigation at abbott molecular identified that some of the 5ml reaction vessels (rv) contained in lots 56944001, 57026001, 57059001 and 57673001 may have insufficient rim. an rv with an insufficient rim may not be held securely in the 1ml subsystem carrier. this may cause the rv to be seated incorrectly in the carrier or drop through it. it is estimated that less than 1% of rvs within these lots may be defective. these lots have been in distribution since july 2012.
Acción
End users are advised to remove them from use any remaining RVs from lots 56944001, 57026001, 57059001, or 57673001 (original vendor lot 2198077). Replacement product will be coordinated on return of the receipt acknowledgement form.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Beckman coulter is advising the users that it is releasing access 2 system software version 3.4.2 and access 2i (unicel dxc 600i system) software version 6.2.2 to address the reagent pack volume issues notification that was distributed august 13, 2010. the notification discussed the risks associated with assay reagent packs that were loaded incorrectly, or reagent packs that were inappropriately transferred between two systems (pack sharing). with these software versions, the new reagent pack monitoring feature enables the access 2 system pressure monitoring hardware to detect packs with insufficient volume, as well as packs that are improperly loaded or missing.
Acción
Beckman Coulter is providing customer-installable 3.4.2 or 6.2.2 software disc along with an information packet that describes the new reagent pack monitoring feature to all customers in Australia. This action has been closed-out on 20/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens is informing customers of potential issue when both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data, missing data and data from a different patient. the risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. a transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
Acción
Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update.
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
Siemens healthcare diagnostics is conducting a correction for the certain estradiol products. it has been confirmed that the drug fulvestrant (faslodex) may cause falsely elevated estradiol results in the assays listed, which could lead the clinician to misinterpret the patient as pre-menopausal possibly leading to altered or discontinued use of the potential beneficial drug fulvestrant.The risk to health applies to all patients being treated with the drug fulvestrant.
Acción
Siemens’ Estradiol assays may continue to be used to report results for patients not on Fulvestrant therapy; these assays should not be used for patients being treated with Fulvestrant. For patients being treated with Fulvestrant, an alternate method such as LC-MS which is not expected to show cross reactivity to Fulvestrant should be used to measure Estradiol concentrations.
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
Abbott has identified that the drug fulvestrant (faslodex) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results. in worst case scenarios, falsely elevated estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy.
Acción
Abbott is advising users that patients undergoing Fulvestrant therapy should not be tested with the Architect Estradiol assay. Users are advised to review this letter with the laboratory Medical Director. This action has been closed-out on 20/02/2017.
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 vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results.Scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a.There is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury.
Acción
Ortho is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. It is recommended to discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. Ortho will be providing users with a software update (software version 3.2.3) as a permanent correction. This can be automatically downloaded for systems connected to e-Connect or software kits provided for systems not connected to e-Connect. This action has been closed-out on 20/02/2017.
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
Siemens healthcare has identified a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. the probability of occurrence is extremely unlikely and other factors such as previous results, patient presentation, and other diagnostic testing would initiate clinical questioning and reduce the potential for injury.
Acción
Siemens Healthcare is advising users of the following:
1. Do not use TestPaks that are due to expire within 48 hours, OR
2. Check Reagent Status to ensure all TestPaks in use have valid calibration expiry dates beyond the TestPak lot expiry date, AND
3. If the laboratory performs routine QC and if using a TestPak that is due to expire within 48 hours, ensure that scheduled QC is performed before running a test.
Siemens Healthcare is currently developing software updates to address this issue and will be providing new information as it becomes available.