Medical Device Recalls
Class I Recall - bioMérieux, Inc. VeriCal® Calibrator Sets

Date Recall
Initiated:

August 19, 2005

Product:

VeriCal® Calibrator Set product catalog number 252585 and lot numbers: 161909, 161813, 161907 and 161908 when used with Simplastin® HTF and Simplastin® L. B.

Use:

The VeriCal® Calibrator Set is used by health professionals performing laboratory tests to measure blood clotting time for patients receiving oral anticoagulation (blood thinning) therapy. The tests are used to monitor the effectiveness of blood thinning medications.

Recalling Firm:

BIOMERIEUX, Inc.
100 Rodolphe Street
Durham, NC 27712-9402

Reason for Recall:

The recalled lots of VeriCal® Calibrator Sets are mislabeled (the specific International Sensitivity Index (ISI) label values published in the packaging were mislabeled for the Multichannel Discrete Analyzer (MDA), Coag-a-Mate MAX and Coag-a-Mate MTX testing analyzer platforms). This could result in misdiagnosis based on inaccurately reported blood clotting time. Misdiagnosis may lead to use of improper levels of oral anticoagulant drugs, resulting in injury to patients, serious illness or death.

Public Contact:

BIOMERIEUX, Inc.
100 Rodolphe Street
Durham, NC 27712-9402
1-800-682-2666

FDA District:

Atlanta

FDA Comments:

• All customers who have received a shipment of the recalled lot numbers of VeriCal® Calibrator Set must immediately stop using the originally published Multichannel Discrete Analyzer® (MDA), Coag-a-Mate® MAX and Coag-a-Mate® MTX specific ISI values and immediately implement the corrected ISI values.
• Corrected published ISI values have been supplied to all customers who have received the concerned VeriCal® Calibrator Set lot numbers.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Consumers with questions may contact the company at 1-800-682-2666 then prompts 3, 2 and 1 or their local bioMérieux Inc. customer service representative.

The company’s press release announcing this recall may be viewed on the FDA Web site at http://www.fda.gov/oc/po/firmrecalls/biomerieux10_05.html.