Z-1045-2012

SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for...

Name: Z-1045-2012 SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for...
Creator: bioMerieux, Inc.
Published: 2011-12-21
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2011-12-21 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus... on 2011-12-21. The reason FDA records is "Reports of false negative results in organism identification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1045-2012
Status: Terminated
Initiated: 2011-12-21
Posted: 2012-02-16
Terminated: 2013-09-17
Recalling firm: bioMerieux, Inc.
Product: SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.
Product code: JWX Kit, Screening, Staphylococcus Aureus
Reason for recall: Reports of false negative results in organism identification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomerieux sent an "URGENT PRODUCT REMOVAL NOTICE" dated December 21, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter instructs the customer to stop using and to destroy the affected products. The firm recommends steps to follow when interpreting results. An acknowledgement and Product Replacement Form was enclosed for the customer to complete and return to the firm. Contact Biomerieux Customer Service representative at (800) 682-2666 for information regarding this notice.
Quantity in commerce: 100 kits
Distribution: Distributed to one customer in California.
Product codes and lots: Catalog #73113, Lot number: 1105104545

Product code JWX

K923212Class ISlidex Staph-KitBiomerieux Vitek, Inc. / cleared 1992-09-28

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)