FDA-Device2019-02-27Class II
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
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
1 kit
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0840-2019Don't want to check this manually?
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