# FDA recall Z-0118-2025

> **Beckman Coulter Inc.** · Class II · device recall initiated 2024-07-31.

## Product

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610    IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

## Reason for recall

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

## Distribution

U.S.:  AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA,  and TX  O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,

## Key facts

- **Recall number:** Z-0118-2025
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-31
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2025

## Citation

> AI Analytics. FDA recall Z-0118-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0118-2025. Source: US FDA. Licensed CC0.

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