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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Mg R1

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 Class 2 Device Recall Randox Mg R1see related information
Date Initiated by FirmNovember 13, 2020
Create DateDecember 08, 2020
Recall Status1 Terminated 3 on April 01, 2021
Recall NumberZ-0546-2021
Recall Event ID 86827
510(K)NumberK974606 
Product Classification Photometric method, magnesium - Product Code JGJ
ProductRandox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Code Information Lot Number: 539734, Exp Date: 28 March 2022  UDI: 05055273204629 
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
FDA Determined
Cause 2		Under Investigation by firm
ActionRandox issued Urgent Medical Device Correction letter via e-mail to US Customers on 13 November 2020 stating reason for recall, health risk and action to take: Discontinue use of and discard any of the above immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical. services@randox.com within five working days. Questions or concerns, please contact Randox Technical Services.
Quantity in Commerce1 kit
DistributionUS Nationwide distribution in the states of GA, NJ.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JGJ
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