Z-2753-2020 Class II Terminated
FDA device recall Z-2753-2020 was initiated by RANDOX LABORATORIES, LTD. on June 26, 2020 and is designated Class II. Reason for recall: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. The recall status is terminated (terminated October 19, 2020).
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 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.
Reason for Recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Code Information
Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI