Recall Z-0840-2019 ยท CJY Azo Dye, Calcium
Randox Laboratories Ltd.
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
| Date | Dec 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Randox the US distributor contacted customers by email on 12/4/18 to advise of problem and provided an update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments.The instrument testing order should be reviewed in line with the updated technical bulletin. A revised letter issued 12 Feb 2019 to advise "reagent would be observed as inconsistencies in Quality control recovery which may lead to a delay in running patient samples or erroneous elevated / depressed test results". |
| Quantity | 1 kit |
| Distribution | WV, PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182042 | Randox Calcium (Ca) Randox Laboratories, Ltd., Oct 23, 2018 |