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Recall -- Firm Press Release

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BioMerieux Issues Worldwide Correction Recall of VeriCal® Calibrator Set

Contact:
BioMerieux, Inc.
800-682-2666

FOR IMMEDIATE RELEASE -- Durham, NC -- October 6, 2005 -- BioMerieux, Inc, Durham, North Carolina, U.S.A., has issued a worldwide voluntary correction recall of VeriCal® Calibrator Sets because they are mislabeled and could result in misdiagnosis or injury to patients serious illness or death from erroneous calibration data leading to use of improper levels of oral anticoagulant drugs. These sets calibrate laboratory tests that are used to monitor a patient’s anticoagulation therapy. reviewed its worldwide voluntary correction recall of VeriCal® Calibrator Set made during August, 2005 and is reclassifying this as a Class I for the lots involved.

The FDA has classified this August, 2005 action as a Class I recall. In a class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.
All customers who have received a shipment of the concerned 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.
This recall involves the following VeriCal® Calibrator Set Product catalog number 252585 and lot numbers: 161909,161813,161907 and 161908 when used with Simplastin® HTF and Simplastin® L.
The VeriCal® Calibrator Set is used for calibration of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) for coagulation assays used in medical laboratory diagnostic testing. Results of the Prothrombin Time, reported in International Normalized Ratio (INR) units, are utilized in the monitoring of oral anticoagulant therapy. This product has been found to be mislabeled, in that 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. The ISI label values are utilized by medical diagnostic laboratories to calculate the reported patient’s Prothrombin Time INR value. This INR value is utilized by physicians to monitor patient’s effective oral anticoagulant therapy response. This mislabeling of the ISI value provided to clinical laboratories could result in discrepant INR values being reported for patients who are receiving oral anticoagulant therapy. While no injuries have been reported to date, t his could lead to either under treatment or over treatment with oral anticoagulant drugs, putting patients in life-threatening situations. This could adversely impact patient therapy.

Corrected published ISI values have been supplied to all customers who have received the concerned VeriCal® Calibrator Set lot numbers.

All customers who have received a shipment of the concerned 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.

This recall involves the following VeriCal® Calibrator Set Product catalog number 252585 and lot numbers: 161909,161813,161907 and 161908 when used with Simplastin® HTF and Simplastin® L. B

BioMerieux has notified the FDA, and has been working with the FDA to coordinate all recall activities.

While no injuries have been reported to date, there is the potential for therapeutic consequences in the routine control of oral anticoagulant therapy.

The product was distributed worldwide, including 437 customers in the US . The recalled product can be identified by product catalog number 252585 the product name, VeriCal® Calibrator Set , on the package label.

BioMerieux, Inc. has notified its distributors and subsidiaries by Field Corrective Action communication and has notified all customers individually of the adjustment in the ISI labeling of all recalled products.

Customers with questions may contact the company at 1-800-682-2666 then prompts 3, 2 and 1 or their local bioMerieux Inc. Customer representative.

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