Z-3129-2011

VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family...

Name: Z-3129-2011 VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family...
Creator: bioMerieux, Inc.
Published: 2011-07-08
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2011-07-08 / Terminated

FDA source

bioMerieux, Inc. began a recall of VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in... on 2011-07-08. The reason FDA records is "Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3129-2011
Status: Terminated
Initiated: 2011-07-08
Posted: 2011-09-02
Terminated: 2012-10-23
Recalling firm: bioMerieux, Inc.
Product: VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.
Product code: LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Reason for recall: Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
FDA root cause: Other
Action: bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" letter dated July 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue using and to destroy any of the affected product. The firm advises customers to confirm all positive results obtained with the affected lot number with another method prior to reporting results. An Acknowledgement and Product Replacement form was attached for customers to complete and return to the firm. Customers should contact their local bioMerieux Customer Service representative for questions regarding this notice.
Quantity in commerce: 283 units
Distribution: Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.
Product codes and lots: Catalog number: 30101-01, Lot number 868400501.

Product code LJC

K905787Class IVidas Chlamydia Assay Vitek Immundiag Assay SystVitek Systems, Inc. / cleared 1991-04-29

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)