Other Medical Devices

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

Potential for breach of Tyvek seals.

Potential for breach of Tyvek seals.

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Potential for breach of Tyvek seals.

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.