Medical Device Safety and Recalls: bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error

A recall has been issued for the bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256.  bioMérieux is recalling the Etest® PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This error may result in inappropriate treatment of a patient’s infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.

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