CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report

Vidas¿ CMV IgM 30 Tests recalled by Biomerieux

Biomerieux is recalling Vidas¿ CMV IgM 30 Tests, distributed nationwide in the US. The recall was initiated on 16 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesref 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)

Quantity recalled18705 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1408-2021
FDA event ID: 87555
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2021
FDA classified: 10 Apr 2021
Reported: 21 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Mar 2021	Recall initiated by company
10 Apr 2021	Classified by FDA	+25 days
21 Apr 2021	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).

Product as listed by the FDA

VIDAS¿ CMV IgM 30 Tests

Where it was distributed

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

Nationwide California Colorado Connecticut Florida Georgia Illinois Indiana Louisiana Massachusetts Michigan Missouri New Jersey Nevada New York Ohio Pennsylvania Texas Virginia Wisconsin West Virginia

Questions about this recall

Is Vidas¿ CMV IgM 30 Tests recalled?

Yes. Biomerieux recalled Vidas¿ CMV IgM 30 Tests on 16 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1408-2021.

Why was it recalled?

bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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