C. Difficile Toxin Gene Amplification Assay

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

The affected lots show a decline in performance over time, which may lead to false-negative results.

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

BD MAX System, BD MAX Instrument

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.

The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), tox

Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

Nanosphere Verigene

Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.