Clinical Chemistry Calibration Serum — Class II medical device recall Z-1759-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-05-15, distributed nationwide. Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL103
| Recall number | Z-1759-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2024-03-05 |
| Classified | 2024-05-03 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 05055273200966 |
| Lot numbers | 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE |
| Model numbers | CAL10388, CAL2351 |
Product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Reason for recall
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
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-1759-2024. 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.