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Terminated

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-0917-04 · Posted 2004-07-20

Recalling FirmbioMerieux Inc
Recall StatusTerminated
Product CodeLON
Date Initiated2004-04-20
Date Terminated2005-04-18
Product Quantity1,990/20-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 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

Distribution Pattern

Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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