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FDAJanuary 22, 2019device

VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

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

The hazard

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

422109983223

Recall history

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

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