FDAJuly 11, 2018device

VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS a...

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

The hazard

The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.

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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