Recalls for Reagents, Clostridium Difficile Toxin

An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.

Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.

The firm is recalling the products due to a potential for false negative test results.

The firm is recalling the products due to a potential for false negative test results.

Leakage in Cepheid SmartCycler reaction tubes.

Leakage in Cepheid SmartCycler reaction tubes.

Leakage in Cepheid SmartCycler reaction tubes.

In vitro diagnostic test kits do not perform to specifications.

The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.

The kits were packaged with incorrect dispensing pipettes.

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.