Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Check against the official notice below — it lists the full affected range.
Randox Laboratories has recalled its Lipase Assay reagent kits due to imprecision issues affecting both quality control and patient test results when using specific batches of the Randox Lipase colorimetric reagent. The lipase test system is designed to measure lipase levels in human blood serum. The affected products were distributed worldwide, including throughout the United States, Puerto Rico, and West Virginia. A total of 2,219 kits are involved in the recall across four catalog numbers (LI3837, LI7979, LI8050, LI8361) with five affected lot numbers: 507360, 497086, 497053, 497038, and 502135.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Reason for recall: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. Distribution: Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV. Quantity: 2219 kits Lot/code info: Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.