BioMérieux Inc. recalls Vitek, the diagnostics firm's antibiotic susceptibility test cards for certain bacterias.
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.
The company notified the FDA of the issues with its products, but commenced and expanded the recall after its own investigations.
"Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant [bacteria]" the company said in a prepared statement.
To date, there have been no reports of adverse events related to the recalled products, according to the company.
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