FDAJune 17, 2019device

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

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

The hazard

Potentially Biased Results using VITROS Chemistry Products GLU Slides

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

00480964928710758750009572

Recall history

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

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