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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Biomerieux Issues New Alert on the Recall of Certain Lots of Its Simplastin Tissue Reagent Used in Laboratory Monitoring of Oral Anticoagulant Therapy

Contact:
BioMerieux, Inc.
800-682-2666

FOR IMMEDIATE RELEASE -- Durham, NC -- May 14, 2005 -- BioMerieux Inc., of Durham NC, is issuing a new alert on a recall of Simplastin HTF, a tissue thromboplastin reagent that is used in laboratory diagnostic testing of patients receiving anticoagulant testing. The new alert is being issued 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.

The recalled product can be identified by product catalog number 259846, lots 161798, 161764, and 161763 or catalog number 259847, lots 161849 and 161800. The recalled lots were distributed worldwide, including 236 customers in the U.S. Laboratories that have this reagent should not use it, but instead contact the company. Laboratories who have used this reagent should also contact any physicians or medical institutions whose patients may be affected by this problem.

Although the company 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 consignees about the importance of this problem and the need to respond to it.

BioMerieux Inc. 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.

Customer with questions may contact the company at 1 800 682 2666 or their local BioMerieux, Inc. customer representative. Patients or healthcare providers with concerns about this issue can also call the company at this number.

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