Z-1047-04

VIDAS CMV IgG Assay

Name: Z-1047-04 VIDAS CMV IgG Assay
Creator: bioMerieux
Published: 2004-06-09
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2004-06-09 / Terminated

FDA source

bioMerieux began a recall of VIDAS CMV IgG Assay on 2004-06-09. The reason FDA records is "The product may give false positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1047-04
Status: Terminated
Initiated: 2004-06-09
Posted: 2004-07-20
Terminated: 2005-01-12
Recalling firm: bioMerieux, Inc.
Product: VIDAS CMV IgG Assay
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: The product may give false positive results.
FDA root cause: Other
Action: Consignees were notified by letter on June 9, 2004.
Quantity in commerce: 148 units
Distribution: AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
Product codes and lots: Catalog #30 204, Lot #782887501

Product code LFZ

K920661Class IIVidas Cmv Igg AssayVitek Systems, Inc. / cleared 1993-02-12

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)