FDA Device recall Z-0118-2025
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Sy…
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Sy… by Beckman Coulter, citing firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-31 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, TX |
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
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Identifiers
| code_info | Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2025%22
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