Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enz

FDA device recall Z-0123-2017 · posted 2016-10-18 · Terminated

Recall details

Recalling firm

Randox Laboratories Ltd.

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.

Action taken

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 technical.services@randox.com. For questions contact Randex Technical Service.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CDT

Quantity affected

18

Distribution

US Nationwide Distribution

Date initiated

2016-08-02

Date posted

2016-10-18

Date terminated

2017-09-07

Location

Crumlin, North, Ireland