---
title: "CMV IgM EIA, in vitro diagnostic. — FDA record Z-0342-2023 | Is It on Recall"
description: "Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA)."
url: https://isitonrecall.com/recall/fda-device-z-0342-2023-cmv-igm-eia-in-vitro-diagnostic/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CMV IgM EIA, in vitro diagnostic. — FDA record Z-0342-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: CMV IgM EIA, in vitro diagnostic.
- **Reason**: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- **Classification**: Class II
- **Recalling firm**: Bio-Rad Laboratories, Inc.
- **Quantity**: 180 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0342-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0342-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Dec 7, 2022
- **Recall initiation date**: Oct 19, 2022
- **Center classification date**: Nov 30, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0342-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Bio-Rad Laboratories, Inc. records](https://isitonrecall.com/brand/bio-rad-laboratories-inc/)