Recall Z-0721-04 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
| Date | Jul 20, 2004 (initiated Jan 28, 2004) |
| Status | Terminated |
| Reason | Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1,988/20-card boxes |
| Distribution | Distribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.