Randox Lipase — Class II medical device recall Z-0123-2017

Terminated recall by Randox Laboratories Ltd., reported 2016-10-26, distributed nationwide. According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and

Recall number	`Z-0123-2017`
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	2016-08-02
Classified	2016-10-18
Reported by FDA	2016-10-26
Terminated	2017-09-07
Distributed	Nationwide (US)
Quantity	18
Reason classes	potency
Model numbers	`LI3837`, `LI7979`, `LI8050`, `LI8361`

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.

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.

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-0123-2017. 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.