Recall Z-0839-2019
Randox Laboratories Ltd. · initiated December 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Codes / lots: All lot codes
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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".
Details
- Recall number
- Z-0839-2019
- Initiated
- December 4, 2018
- Terminated
- June 18, 2020
- Product code
- CJY – Azo Dye, Calcium
- Quantity
- 225 kits
- Distribution
- WV, PR
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0840-2019 Class II | Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo…Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover… | 12/04/2018Terminated |