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

Recall date

December 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0839-2019

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

WV, PR

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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