Device product
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Z-0839-2019
Product summary
- Event
- Event 81746
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 kits
- Official record key
device-enforcement:Z-0839-2019
Official wording
Reason: 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.
Code information: All lot codes
Distribution pattern: WV, PR
Derived failure modes
-
Unknown
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.