Recall Z-0123-2017— Randox Laboratories Ltd.

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2016-08-02, terminated 2017-09-07. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Randox Laboratories Ltd.

Classification

Class II

Status

Terminated

Initiated

2016-08-02

Terminated

2017-09-07

Firm location

Crumlin (North), N/A, Ireland

Data sourced from openFDA. This site is unofficial and independent of the FDA.