Recall Z-0725-04 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
| Date | Jul 20, 2004 (initiated Jan 15, 2004) |
| Status | Terminated |
| Reason | The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1,955/20-card boxes |
| Distribution | Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.