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FDAAugust 15, 2018device

VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915

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

The hazard

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

Recall history

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

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