FDA-Device2019-02-27Class II
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Randox Laboratories Ltd.
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.
Sold states
WV, PR
Affected count
225 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0839-2019Don't want to check this manually?
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