bioMerieux Inc VITEK GPS-107Gram 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITEK GPS-107Gram 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.
Brand
bioMerieux Inc
Lot Codes / Batch Numbers
Lot #M83X, Exp. 4/15/05
Products Sold
Lot #M83X, Exp. 4/15/05
bioMerieux Inc is recalling VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 card due to Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
Recommended Action
Per FDA guidance
The firm issued recall letters dated 1/28/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. A 'Second Notification' recall letter was issued 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