Z-1631-2018 Class II Terminated
FDA device recall Z-1631-2018 was initiated by Randox Laboratories Ltd. on Mar 2, 2018 and is designated Class II. Reason for recall: Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. The recall status is terminated (terminated Apr 11, 2019). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 2, 2018
- Termination Date
- Apr 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
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.
Distribution Pattern
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Code Information
Lot numbers: 428000, 404175, and 404245
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1631-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026