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FDAJune 14, 2024device

Alinity hq Analyzer, REF: 09P68-01

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

The hazard

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

380740138851

Recall history

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

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