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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK GPS107 Gram Positive Susceptibility Card

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  Class 2 Device Recall VITEK GPS107 Gram Positive Susceptibility Card see related information
Date Initiated by Firm April 20, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 18, 2005
Recall Number Z-0919-04
Recall Event ID 28872
Product Classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
Product VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
Code Information Lot #P108X
Recalling Firm/
Manufacturer		 bioMerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Nancy Weaver
314-731-8695
Manufacturer Reason
for Recall		 Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
FDA Determined
Cause 2		 Other
Action The firm issued recall letters dated 4/20/04 via certified mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported.
Quantity in Commerce 1,760/20-card boxes
Distribution Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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