# FDA recall Z-1408-2021

> **Biomerieux Inc** · Class II · device recall initiated 2021-03-16.

## Product

VIDAS¿  CMV IgM 30 Tests

## Reason for recall

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

## 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

## Key facts

- **Recall number:** Z-1408-2021
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-16
- **Report date:** 2021-04-21
- **Termination date:** 2024-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2021

## Citation

> AI Analytics. FDA recall Z-1408-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1408-2021. Source: US FDA. Licensed CC0.

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