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

UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI 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. The UniCel — recall Z-0346-2013

U.S. FDA — Device Enforcement · United States · 2011-08-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0346-2013
Date of alert: 2011-08-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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