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

Recall Z-2687-2014 — UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to

U.S. FDA — Device Enforcement · United States · 2014-08-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2687-2014
Date of alert
2014-08-21
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 Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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