bioMerieux Inc VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.
Brand
bioMerieux Inc
Lot Codes / Batch Numbers
Lot P61X, Exp. 5/12/05
Products Sold
Lot P61X, Exp. 5/12/05
bioMerieux Inc is recalling VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 car due to The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
Recommended Action
Per FDA guidance
The firm issued recall letters dated 1/15/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. The firm also issued a 'Second Notification' recall letter dated 3/9/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026