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

Recall Z-0239-2016 — Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

U.S. FDA — Device Enforcement · United States · 2015-10-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0239-2016
Date of alert
2015-10-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Reported risk: Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
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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