Calibration Serum Level 3 — Class II medical device recall Z-0751-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-01-24, distributed nationwide. There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL23
| Recall number | Z-0751-2024 |
|---|---|
| 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 | 2023-11-13 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 05055273200966 |
| Lot numbers | 1260UE, 1262UE, 1315UE |
| Model numbers | CAL2351 |
| Expiration dates | 2024-11-28, 2025-01-28, 2025-05-28 |
Product
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Reason for recall
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
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-0751-2024. 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.