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

Recall Z-2428-2024 — Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

U.S. FDA — Device Enforcement · United States · 2024-05-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2428-2024
Date of alert: 2024-05-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15099590011598

Reported risk: LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

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.

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.

Recall Z-2428-2024 — Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

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