Z-1631-2018Class II

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284

Name: Z-1631-2018 Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284
Creator: Randox Laboratories Ltd.
Published: 2018-03-02
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-03-02 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative... on 2018-03-02. FDA classified it as Class II and gives the reason as "Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1631-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-02
Posted: 2018-05-04
Terminated: 2019-04-11
Recalling firm: Randox Laboratories, Limited
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.
Product code: CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Reason for recall: Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
FDA root cause: Under Investigation by firm
Action: On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to [email protected] within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Customer with questions may contact Randox Technical Services via e-mail [email protected] or by phone +44 (0) 28 9445 1070
Quantity in commerce: 8
Distribution: US Nationwide Distribution in the states of West Virginia and Puerto Rico
Product codes and lots: Lot numbers: 428000, 404175, and 404245

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1631-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1631-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code CDT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)