medical Class II Updated 2019-02-27

Randox Laboratories Ltd. recalls Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No.

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: WV
Lot/Code Info: All lot codes
View official government recall

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