Reported Oct 26, 2016 · Terminated
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Randox
- Lipase (Colorimetric) Product UsageA 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
- Lot codes and dates
- Catalogue number
LI3837LI7979LI8050LI8361
- Catalogue number
- Amount recalled
- 18
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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