Randox CALCIUM — Class II medical device recall Z-0839-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-02-27, distributed in PR, WV. Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoid
| Recall number | Z-0839-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2018-12-04 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-06-18 |
| Distributed | PR, WV |
| Quantity | 225 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273200904 |
| Model numbers | 3871 |
Product
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0839-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.