VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The r
FDA device recall Z-0721-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- bioMerieux Inc
- Reason for recall
- Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 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.
- Date initiated
- 2004-01-28
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-18
- Location
- Hazelwood, MO
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