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

Recall Z-1014-2017 — DxH 600 Coulter Cellular Analysis System, Catalog No. B23858

U.S. FDA — Device Enforcement · United States · 2016-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1014-2017
Date of alert
2016-12-19
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 has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
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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