FDA Device recall Z-0840-2019
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat by Randox Laboratories, citing 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 Calci….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0840-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-04 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | PR, WV |
Product
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
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.
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0840-2019%22
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