Recall Z-2752-2020 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
RANDOX LABORATORIES, LTD.
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.
| Date | Aug 4, 2020 (initiated Jun 26, 2020) |
| Status | Terminated |
| Reason | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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. |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.