This is an in vitro diagnostic product intended for use as a… — Class III medical device recall Z-2490-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-09-18, distributed nationwide. Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line wit
| Recall number | Z-2490-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2019-07-12 |
| Classified | 2019-09-07 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AW, BS |
| Quantity | 307 kits |
| UPC / GTIN / UDI-DI | 05055273200966 |
| Lot numbers | 961UE |
Product
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Reason for recall
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
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-2490-2019. 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.