Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0118-2025 — 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.

U.S. FDA — Device Enforcement · United States · 2024-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0118-2025
Date of alert
2024-07-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590221195
Reported risk: Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.