Randox Blood Gas Control Level 2 -Model BG5002 — Class II medical device recall Z-1057-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-04-03, distributed in WV. An error in the assignment of the control range pH in Blood Gas Control
| Recall number | Z-1057-2019 |
|---|---|
| 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 | 2019-02-13 |
| Classified | 2019-03-26 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-04-14 |
| Distributed | WV |
| Quantity | 1 kits |
| UPC / GTIN / UDI-DI | 05055273227116 |
| Lot numbers | 184BG |
| Model numbers | BG5002 |
Product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Reason for recall
An error in the assignment of the control range pH in Blood Gas Control
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-1057-2019. 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.