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FDAFebruary 20, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear