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Class I recall

This article was originally published in The Gray Sheet

Executive Summary

BioMerieux's VeriCal calibrator set recall has been designated Class I by FDA. The French company initiated the action in August because units are mislabeled and "could result in misdiagnosis or injury to patients, serious illness or death from erroneous calibration data leading to use of improper levels of oral anticoagulant drugs," the firm says. The in vitro diagnostic device, which has been distributed worldwide - including to 437 customers in the U.S. - is used to calibrate prothrombin time and activated partial thromboplastin time for coagulation assays. BioMerieux was involved in another Class I recall in March related to the mislabeling of MDA Simplastin human thromboplastin factor tissue reagents. The firm received warning letters from FDA in July 2004 and July 2005 citing quality system lapses at its Durham, N.C. manufacturing plant (1"The Gray Sheet" Aug. 30, 2004, p. 26)...

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