Randox Lipase Assay: Lipase Colorimetric R2 Substrate — Class II medical device recall Z-2753-2020
Terminated recall by RANDOX LABORATORIES, LTD., reported 2020-08-12, distributed nationwide. Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2
| Recall number | Z-2753-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RANDOX LABORATORIES, LTD., Crumlin Colorado Antrim, United Kingdom |
| Recall initiated | 2020-06-26 |
| Classified | 2020-08-04 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2020-10-19 |
| Distributed | Nationwide (US) |
| Lot numbers | 1049LI, 1051LI |
| Model numbers | LI015/000/UL, LI015/003/UL |
Product
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Reason for recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
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-2753-2020. 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.