medical Class II Updated 2020-08-12

RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric Reagent - Product U

Recalled Product

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.

Hazard / Issue

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
View official government recall

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