bioMérieux recall redux
This article was originally published in The Gray Sheet
Executive Summary
Firm's April 20 recall of Vitek GPS-107 gram positive sensibility cards (lot B28E) is deemed Class I by FDA in 1May 6 letter. bioMérieux received a similar agency communication March 19 regarding the January recall of a separate GPS-107 lot. The recalled cards - used with the automated Vitek for antibiotic susceptibility testing - could report results as if they were GPS-105 cards, which contain ampicillin, levofloxacin and amoxicillin. The first recalled lot affected an estimated 95 clinical laboratory customers (2"The Gray Sheet" March 29, 2004, p. 11)...
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