Device 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.
Z-2751-2020
Product summary
- Event
- Event 86039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2219 kits
- Official record key
device-enforcement:Z-2751-2020
Official wording
Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Code information: Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Derived failure modes
-
Unknown
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.