bioMerieux, Inc. Expands Global Recall for Anti-Bacterial Tests
Mass Device -- BioMerieux Inc. expanded its worldwide recall of a test for certain bacterias' resistance to a type of antibiotic. The French French medical diagnostics maker's Vitek 2 Gram Negative Susceptibility Cards designed to test bacteria for susceptibility to the antibiotic Piperacillin/Tazobactam (TZP) were found to provide inaccurate results.
BioMerieux's previous recall informed users that "due to performance issues," users should test all E. coli strains, and Klebsiella pneumoniae by an alternative method, but a subsequent internal investigation conducted found that the Vitek 2 test may also incorrectly determine M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P aeruginosa and S. enterica sensitivity to TZP.