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FDAAugust 11, 2016device

VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.

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

The hazard

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750000340

Recall history

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

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