Z-1209-03

VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

Name: Z-1209-03 VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
Creator: bioMerieux
Published: 2003-08-06
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2003-08-06 / Terminated

FDA source

bioMerieux began a recall of VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101 on 2003-08-06. The reason FDA records is "Product's decrease in sensitivity may result in false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1209-03
Status: Terminated
Initiated: 2003-08-06
Posted: 2003-10-15
Terminated: 2005-05-17
Recalling firm: bioMerieux, Inc.
Product: VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
Product code: LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Reason for recall: Product's decrease in sensitivity may result in false negative results
FDA root cause: Other
Action: On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.
Quantity in commerce: 2204
Distribution: Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
Product codes and lots: Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004

Product code LJC

K915884Class IVidas Chlamydia Assay, ModificationVitek Systems, Inc. / cleared 1992-03-04

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)