Z-2752-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 26, 2020
- Termination Date
- October 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Reason for Recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Code Information
Catalogue Numbers: LI011/004/UL, LI011/000/UL Lot #: 1048LI, 1050LI