VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The
FDA device recall Z-0725-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- bioMerieux Inc
- Reason for recall
- The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 1,955/20-card boxes
- Distribution
- Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
- Date initiated
- 2004-01-15
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-24
- Location
- Hazelwood, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.