Z-0725-04

VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per...

Name: Z-0725-04 VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per...
Creator: bioMerieux Inc
Published: 2004-01-15
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2004-01-15 / Terminated

FDA source

bioMerieux Inc began a recall of 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... on 2004-01-15. The reason FDA records is "The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0725-04
Status: Terminated
Initiated: 2004-01-15
Posted: 2004-07-20
Terminated: 2004-11-24
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
FDA root cause: Other
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.
Quantity in commerce: 1,955/20-card boxes
Distribution: Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
Product codes and lots: Lot P61X, Exp. 5/12/05

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)