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

Recall Z-2545-2024 — Discrete photometric chemistry analyzer for clinical use.

U.S. FDA — Device Enforcement · United States · 2024-06-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2545-2024
Date of alert
2024-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
150995901
Reported risk: Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.