Performance Shift Causes bioMerieux to Recall Etest Kits

bioMerieux is recalling 3,760 units of its Etest PIP/TAZO/CON-4 PTC 256 because its results could indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria, when it may not be effective in doing so.

This error could result in inappropriate treatment of infection, leading to serious health consequences, according to a notice posted on the FDA’s website. bioMérieux sent an urgent product removal notice to customers beginning Nov. 24, 2015, advising them to stop using the affected product and discard any remaining inventory.

Ireland’s Health Products Regulatory Authority issued a safety notice in mid-December that advised patients to stop using Etest kits that include piperacillin/tazobactam antibiotic, following the recall.

The manufacturer received reports from customers of low minimum inhibitory concentrations. Data analysis showed the performance of the test has shifted when compared with the published characteristics, bioMerieux says in a field safety notice.

The Etest potentially could report false susceptibility results for piperacillin/tazobactam, the company says. “This risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy,” it adds.

The recall — designated Class I by the FDA — covers tests manufactured from Dec. 20, 2012 to Oct. 23, 2015, and distributed between Jan. 24, 2013 and Nov. 9, 2015.

bioMerieux did not respond to a request for comment by press time.

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