Human Assayed Multi-Sera Level 2 — Class II medical device recall Z-2150-2019
Terminated recall by Randox Laboratories, Limited, reported 2019-08-14, distributed nationwide. The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT h
| Recall number | Z-2150-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2019-06-11 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 149 |
| Model numbers | HN1530 |
Product
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Reason for recall
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
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-2150-2019. 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.