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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Lipase Assay: Lipase Colorimetric R2 Substrate

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  Class 2 Device Recall Randox Lipase Assay: Lipase Colorimetric R2 Substrate see related information
Date Initiated by Firm June 26, 2020
Date Posted August 04, 2020
Recall Status1 Terminated 3 on October 19, 2020
Recall Number Z-2753-2020
Recall Event ID 86039
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
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.
Code Information Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI
Recalling Firm/
Manufacturer		 RANDOX LABORATORIES, LTD.
34 Diamond Rd
Crumlin Colorado Antrim United Kingdom
For Additional Information Contact Louise Lynn
44-28-94422413
Manufacturer Reason
for Recall		 Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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