Recalls / —
—#31833
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.
- FDA product code
- LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot P61X, Exp. 5/12/05
Why it was recalled
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- bioMerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
Timeline
- Recall initiated
- 2004-01-15
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-11-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.