—#31841

Product

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 product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot #M83X, Exp. 4/15/05

Why it was recalled

Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: bioMerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

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.

Timeline

Recall initiated: 2004-01-28
Posted by FDA: 2004-07-20
Terminated: 2005-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.