Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2753-2020 · Posted 2020-08-04

Recalling FirmRANDOX LABORATORIES, LTD.
Recall StatusTerminated
Product CodeCHI
Date Initiated2020-06-26
Date Terminated2020-10-19

Reason for Recall

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑