IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF… — Class II medical device recall Z-0118-2025
Ongoing recall by Beckman Coulter Inc., reported 2024-10-23, distributed in AZ, CA, CO, FL, GA, HI, IL, MA…. Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
| Recall number | Z-0118-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2024-07-31 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, TX |
| Countries outside the US | AU, BE, BR, CL, CN, CZ, DE, EC, ES, FR, GR, HK, IN, IT, KW, MX, PH, PL, PT, SA, SE, SK, TR, TW |
| Quantity | 12,102 reagents |
| UPC / GTIN / UDI-DI | 15099590221195 |
| Lot numbers | M307362, M309410 |
| Model numbers | 447610, 447610IGM |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0118-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.