Z-0742-2022Class II

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx

Name: Z-0742-2022 VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx
Creator: bioMerieux, Inc.
Published: 2022-02-09
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2022-02-09 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx on 2022-02-09. FDA classified it as Class II and gives the reason as "Invalid calibrations (out of range high) while using the product". 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-0742-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-09
Posted: 2022-03-14
Terminated: 2026-04-01
Recalling firm: bioMerieux, Inc.
Product: VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Product code: LKQ Antibody Igm,If, Cytomegalovirus Virus
Reason for recall: Invalid calibrations (out of range high) while using the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.
Quantity in commerce: 480 kits
Distribution: Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
Product codes and lots: Lot numbers 1008873260, exp. 01JUN2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0742-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2022	Class II	Terminated	Voluntary: Firm initiated	2022-10-05	2022-03-14

Product code LKQ

K933549Class IIVidas Cmv Igm AssayBiomerieux Vitek, Inc. / cleared 1994-08-02

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)