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U.S. Department of Health and Human Services


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BioMerieux VeriCal Calibrator Set

Audience: Laboratory supervisory personnel and healthcare professionals

[UPDATE 10/14/2005] Class I recall notice added below

[Posted 09/16/2005] BioMerieux and FDA notified healthcare professionals of a recall of VeriCal Calibrator Set, used to calibrate the Prothrombin Time (PT) and Activated Partial Thromboplastin Times (APTT) on bioMerieux instrument platforms. This recall only impacts INR determinations derived from Prothrombin Tim (PT) results on the following instrument platforms: MDA Coag-A-Mate MTX and Coag-A-Mate MAX. The recall is due to the mis-assignment of ISI values associated with VeriCal use. These calibrated ISI values are currently provided on Simplastin HFT and Simplastin L product labeling. The VeriCal labeling currently contains PT time in seconds and is being revised to include ISI assignment for specified reagents. The product recall notice offers detailed recommendations for action by laboratory personnel using these products.

[November 14, 2005 - Recall Notice - FDA]
[August 31, 2005 - Recall Notice - BioMerieux Inc.]

Related MedWatch safety alert: [May 16, 2005]