Randox Rx Series Mg — Class II medical device recall Z-0547-2021
Terminated recall by Randox Laboratories Ltd., reported 2020-12-16, distributed nationwide. Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approxi
| Recall number | Z-0547-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2020-11-13 |
| Classified | 2020-12-08 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2021-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 4 kits |
| UPC / GTIN / UDI-DI | 05055273209303 |
| Lot numbers | 539770 |
| Model numbers | MG8326 |
| Expiration dates | 2022-03-28 |
Product
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Reason for recall
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
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-0547-2021. 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.