VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The
FDA device recall Z-0919-04 · 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 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 1,760/20-card boxes
- Distribution
- Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
- Date initiated
- 2004-04-20
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-18
- Location
- Hazelwood, MO
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