Device 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.
Z-2753-2020
Product summary
- Event
- Event 86039
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2753-2020
Official wording
Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Code information: Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI
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 R2 Substrate batches.