Z-1408-2021Class II

VIDAS CMV IgM 30 Tests

Name: Z-1408-2021 VIDAS CMV IgM 30 Tests
Creator: Biomerieux Inc
Published: 2021-03-16
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-03-16 / Terminated / root cause: manufacturing process

FDA source

Biomerieux Inc began a recall of VIDAS CMV IgM 30 Tests on 2021-03-16. FDA classified it as Class II and gives the reason as "bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01)". 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-1408-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-16
Posted: 2021-04-10
Terminated: 2024-08-06
Recalling firm: bioMerieux, Inc.
Product: VIDAS CMV IgM 30 Tests
Product code: LKQ Antibody Igm,If, Cytomegalovirus Virus
Reason for recall: bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: A Recall notification letter titled, "IMPORTANT: URGENT FIELD SAFETY NOTICE" was sent to the to the impacted subsidiaries and distributors on 03/16/2021 via email. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The recalling firm requested that the consignees conduct the following actions: 1 - Please distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product. 2 - Stop using and destroy any stock of lots VIDAS CMV IgM (Ref. 30205 and 30205-01) lots mentioned in Table 1 remaining in their inventory and not already discarded through the Urgent Field Safety notice related to FSCA#5087 3 - Complete the Acknowledgement Form in Attachment A and return it to their local bioMrieux representative to confirm receipt of this notice. 4 - Contact their local customer service if they have any questions.
Quantity in commerce: 18705 kits
Distribution: Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Fed., Sweden, Singapore, Thailand, Turkey, South Africa, Algeria, Angola, Bahrain, Belarus, Benin, Bolivia, Bosnia-Herz., Bulgaria, Burkina Faso, Cameroon, Cape Verde, Chad, Costa Rica, Croatia, Dem. Rep. Congo, Dominican Rep., Dutch Antilles, Ecuador, El Salvador, Georgia, Guatemala, Indonesia, Iran, Iraq, Israel, Kenya, Lebanon, Lithuania, Macedonia, Mali, Malta, Mongolia, Morocco, Mozambique, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sril Lanka, Syria, Tunisia, Uruguay, Utd.Arab Emir., Vietnam, Djibouti, Equatorial Guin, Zambia, Cap Verde
Product codes and lots: ref 30205; lot numbers 1008143230 (exp. date: 04 MAY 2021), 1008182270 (exp. date: 26 MAY 2021), 1008363970 (exp. date: 01 SEP 2021), 1008433580 (exp. date: 15 OCT 2021) US ref 30205-01; lot numbers 1008143260 (exp. date: 04 MAY 2021) and 1008363980 (exp. date: 01 SEP 2021)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1408-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1408-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-10

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)