Lipase — Class II medical device recall Z-1631-2018
Terminated recall by Randox Laboratories Ltd., reported 2018-05-16, distributed nationwide. Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
| Recall number | Z-1631-2018 |
|---|---|
| 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 | 2018-03-02 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273204230, 05055273214284 |
| Lot numbers | 404175, 404245, 428000 |
| Model numbers | LI3837, LI8361 |
Product
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Reason for recall
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
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-1631-2018. 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.