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U.S. Department of Health and Human Services

Class 2 Device Recall Randox CK Total in Calibration Serum Level 3

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 Class 2 Device Recall Randox CK Total in Calibration Serum Level 3see related information
Date Initiated by FirmNovember 20, 2023
Date PostedJanuary 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0752-2024
Recall Event ID 93612
510(K)NumberK053153 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductCalibration Serum Level 3 CAL2351
Code Information GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
FDA Determined
Cause 2		Under Investigation by firm
ActionRandox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce269 kits
DistributionUS Nationwide and Puerto Rico.
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 = JIX
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