medical Class II Updated 2020-08-12

RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Prod

Recalled Product

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - 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 R2 Substrate batches.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI
View official government recall

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