Recalls / —
—#32663
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.
- FDA product code
- LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot #P108X
Why it was recalled
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- bioMerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
Timeline
- Recall initiated
- 2004-04-20
- Posted by FDA
- 2004-07-20
- Terminated
- 2005-04-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #32663. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.