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U.S. Department of Health and Human Services


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BioMerieux Simplastin HTF Tissue Reagent

Audience: Laboratory supervisory personnel and healthcare professionals

BioMerieux and FDA notified healthcare professionals of a class 1 recall of MDA Simplastin HTF (human thromboplastin factor) tissue reagent, a tissue thromboplastin reagent used in determination of the prothrombin time (PT) in human plasma. The prothrombin time (PT) laboratory test is used to control the use of oral anticoagulant therapy, (i.e. Coumadin) in patients with bleeding disorders. Mislabeling problems with certain lots of this product could result in inaccurate test results, which in turn could lead to improper patient treatment – in some cases resulting in serious or life-threatening injury. Although BioMerieux initiated a recall of these products in March 2005, its notifications to purchasers incorrectly indicated that the problem was of no clinical significance. The company is now clearly informing its customers about the importance of this problem and the need to respond to it. Laboratories that have this reagent should not use it, but instead contact the company. Laboratories that have used this reagent should also contact any physicians or medical institutions whose patients may be affected by this problem.

[May 16, 2005 - Recall Notice - FDA]