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

Recall Z-1074-2019 — CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

U.S. FDA — Device Enforcement · United States · 2019-02-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1074-2019
Date of alert
2019-02-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
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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