FDA Device recall Z-1631-2018
Lipase, Catalog number: LI3837
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Lipase, Catalog number: LI3837 by Randox Laboratories, citing randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1631-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-02 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | US |
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
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Identifiers
| code_info | Lot numbers: 428000, 404175, and 404245 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2018%22
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