# FDA recall Z-0342-2023

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2022-10-19.

## Product

CMV IgM EIA, in vitro diagnostic.

## Reason for recall

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

## Distribution

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX  O.U.S.: None

## Key facts

- **Recall number:** Z-0342-2023
- **Recalling firm:** Bio-Rad Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-19
- **Report date:** 2022-12-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2023

## Citation

> AI Analytics. FDA recall Z-0342-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0342-2023. Source: US FDA. Licensed CC0.

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