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FDAJuly 25, 2019device

Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

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

The hazard

Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

Recall history

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

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