BioMérieux Recalls Test Over Errors in Results
BioMérieux 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 and could cause serious health consequences, according to a notice posted on the FDA’s website.
bioMérieux sent an urgent product removal notice to customers beginning on Nov. 24, advising them to stop using the affected product and discard any remaining inventory.
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. — Michael Cipriano