All Recalls

An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU

Devices had cracked or detached from the feeding tube body

Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.

Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results

Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.

The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

Incorrect expiration date included in test kit labeling and/or in Substrate component label.

COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.

Incorrect expiration date included in test kit labeling and/or in Substrate component label.

Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.