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U.S. Department of Health and Human Services

Medical Devices

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BioMerieux Simplastin HTF Tissue Reagent

Class 1 Recall
Date Recall
Initiated:

March 7, 2005

Product:

MDA Simplastin HTF (human thromboplastin factor) tissue reagents, 20 ml H2O, product catalog number 259846, lots 161798, 161764 and 161763 or product catalog number 259847, lots 161849 and 161800. The recalled lots were distributed worldwide, including 236 customers in the U.S.

Use:

Simplastin HTF is 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.

Recalling Firm:

BioMerieux Inc.
100 Rodolphe St
Durham, N.C. 27712-9402

Reason for Recall:

BioMerieux initiated a recall because 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.

Public Contact:

Customers with questions may contact BioMerieux at 1-800-682-2666 or they may contact their local BioMerieux customer representative. Patients or healthcare providers with concerns can also call the company at the 800 number listed.

FDA District:

Atlanta

FDA Comment:

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. BioMerieux is notifying its distributors and subsidiaries by Field Corrective Action communication and has notified all customers individually about the change in the recall’s status.

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.

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.

  For additional information on this product recall, see nearby links.