RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
Lot Codes / Batch Numbers
Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
Products Sold
Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom is recalling Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device i due to Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Recommended Action
Per FDA guidance
Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026