Z-0123-2017Class II

Randox Lipase (Colorimetric)

Name: Z-0123-2017 Randox Lipase (Colorimetric)
Creator: Randox Laboratories Ltd.
Published: 2016-08-02
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2016-08-02 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase... on 2016-08-02. FDA classified it as Class II and gives the reason as "According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0123-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-10-18
Terminated: 2017-09-07
Recalling firm: Randox Laboratories, Limited
Product: Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in 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: According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides. A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Randex Laboratories sent an Urgent Field Safety Notice letter dated June 17, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the response section of this form [email protected]. For questions contact Randex Technical Service.
Quantity in commerce: 18
Distribution: US Nationwide Distribution
Product codes and lots: Catalogue number: LI3837, LI7979, LI8050, LI8361

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

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)