Letter to bioMèrieux, Inc.
May 6, 2004
Via FedEx
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 B28E.
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-0917-04 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,
/S/
Daniel G. Schultz, MD
Acting Director
Center for Devices and Radiological Health
Cc:
Fax bioMèrieux President
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