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U.S. Department of Health and Human Services

Class 2 Device Recall Lipase

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  Class 2 Device Recall Lipase see related information
Date Initiated by Firm March 02, 2018
Create Date May 04, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall Number Z-1631-2018
Recall Event ID 79767
Product Classification Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
Product Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284

Product Usage:
For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Code Information Lot numbers: 428000, 404175, and 404245
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information Contact Mariclare McGarrity
44-02894422413
Manufacturer Reason
for Recall		 Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to technical.services@randox..com within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Customer with questions may contact Randox Technical Services via e-mail technical.services@randox.com or by phone +44 (0) 28 9445 1070
Quantity in Commerce 8
Distribution US Nationwide Distribution in the states of West Virginia and Puerto Rico
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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