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U.S. Department of Health and Human Services

Class 2 Device Recall Magnesium on RX Imola analyser

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  Class 2 Device Recall Magnesium on RX Imola analyser see related information
Date Initiated by Firm April 14, 2016
Create Date December 08, 2016
Recall Status1 Terminated 3 on September 19, 2017
Recall Number Z-0725-2017
Recall Event ID 75263
510(K)Number K052914  
Product Classification Photometric method, magnesium - Product Code JGJ
Product Magnesium on RX Imola analyser
IVD
Code Information reagent: MG3880 analyser: RX4900 
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore 55 The Diamond Road
Crumlin United Kingdom
Manufacturer Reason
for Recall		 According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction.
FDA Determined
Cause 2		 Device Design
Action Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com.
Quantity in Commerce 15
Distribution Nationwide Distribution The product was only distributed to US Consignees.
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.
510(K) Database 510(K)s with Product Code = JGJ and Original Applicant = RANDOX LABORATORIES, LTD.
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