AM1054 Randox Ammonia — Class II medical device recall Z-2966-2020
Terminated recall by RANDOX LABORATORIES, LTD., reported 2020-09-23, distributed in UT, VA, WV. Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being obse
| Recall number | Z-2966-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RANDOX LABORATORIES, LTD., Crumlin Colorado Antrim, N/A, United Kingdom |
| Recall initiated | 2020-07-30 |
| Classified | 2020-09-14 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-02-03 |
| Distributed | UT, VA, WV |
| Countries outside the US | CA |
| Quantity | 143 kits |
| UPC / GTIN / UDI-DI | 05055273200263 |
| Lot numbers | 512103 |
| Model numbers | AM1054 |
Product
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Reason for recall
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient 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-2966-2020. 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.