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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Lipoprotein (a) reagent

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 Class 2 Device Recall Randox Lipoprotein (a) reagentsee related information
Date Initiated by FirmDecember 20, 2024
Date PostedJanuary 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1017-2025
Recall Event ID 96043
510(K)NumberK011568 
Product Classification Lipoprotein, low-density, antigen, antiserum, control - Product Code DFC
ProductRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Code Information UDI-DI: 05055273204421 All lots within expiry
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
For Additional Information ContactLouise Lynn
289442-2413
Manufacturer Reason
for Recall		Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
FDA Determined
Cause 2		No Marketing Application
ActionRandox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce15 kits
DistributionUS Nationwide distribution Including PR.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DFC
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