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.
FDA Recall Z-0721-04 · Posted 2004-07-20
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Recalling FirmbioMerieux Inc
Recall StatusTerminated
Product CodeLON
Date Initiated2004-01-28
Date Terminated2005-04-18
Product Quantity1,988/20-card boxes
Reason for Recall
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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