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FDADecember 4, 2018device

Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

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

The hazard

Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273200904

Recall history

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

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