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Letter to bioMèrieux, Inc.

DEPARTMENT OF HEALTH & HUMAN SERVICES

March 19, 2004

Mr. Philipp Sans
President and CEO
bioMèrieux, Inc.
100 Rodolphe Street
Building 1300
Durham, NC 27712

Dear Mr. Sans:

This is in reference to your firm’s recall of the VITEK GPS-107 gram positive susceptibility card, lot M83X.

The Food and Drug Administration (FDA) has reviewed the information obtained from your firm concerning this matter. We have concluded that the defect, an unknown percentage of the affected lot was erroneously stamped with a card code that causes the VITEK reader to read the GPS-107 cards and report the results as if they were VITEK GPS-105 cards, exposed patients whose samples were analyzed by this device to a risk of potentially life threatening consequences due to inaccurate test results. We are, therefore, classifying your voluntary action as a Class I recall, and are assigning recall number Z-0721-04 to it.

The seriousness of this defect requires level A (100%) effectiveness checks. Your firm should verify that every consignee has been notified of the recall. The physicians who ordered the tests affected by the device defect should be notified about the potential error on the reported results. This type of physician notification is usually conducted by the laboratory that used the defective devices since the laboratory has the information on the affected patients and their physicians. Your firm should work with the affected laboratories to facilitate the distribution of this notification. The need for retesting should be left at the physician’s discretion and any questions to this regard should be directed to you.

The Food and Drug Administration’s policy concerning recalls is located in Title 21, Code of Federal Regulations, Part 7. Information regarding your recall will be published in the weekly FDA Enforcement Report.

The Kansas District Office will remain in close contact with your firm regarding this recall until this matter is resolved.

Sincerely yours,

David W. Feigal, Jr., M.D., M.P.H.
Director
Center for Devices and Radiological Health

Page updated March 29, 2004