Reported May 16, 2018 · Terminated

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage:…

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?

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
LI3837Lipase
LI836105055273204230GTIN: 05055273204230 and
05055273214284Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human 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
  • Lot numbers
    • 428000
    • 404175
    • and 404245
Amount recalled
8

Where it was sold

Why it was recalled

Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 11, 2019 · Data as of Sep 19, 5:29 PM UTC

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