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Terminated

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.

FDA Recall Z-1631-2018 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeCDT
Date Initiated2018-03-02
Date Terminated2019-04-11
Product Quantity8

Reason for Recall

Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.

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 [email protected] 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 [email protected] or by phone +44 (0) 28 9445 1070

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution in the states of West Virginia and Puerto Rico

Official Source

View FDA Recall →

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

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