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FDAMay 9, 2019device

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

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

The hazard

The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.

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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Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. — Recall Details · AllClear