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

Recall Z-0291-2014 — Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

U.S. FDA — Device Enforcement · United States · 2013-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0291-2014
Date of alert
2013-09-12
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 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
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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