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.
FDA Recall Z-0725-04 · Posted 2004-07-20
Recalling FirmbioMerieux Inc
Recall StatusTerminated
Product CodeLON
Date Initiated2004-01-15
Date Terminated2004-11-24
Product Quantity1,955/20-card boxes
Reason for Recall
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
Firm 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.
Root Cause
Other
Distribution Pattern
Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.