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U.S. Department of Health and Human Services

Class 2 Device Recall Calibration Serum Level 3

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 Class 2 Device Recall Calibration Serum Level 3see related information
Date Initiated by FirmNovember 20, 2023
Date PostedJanuary 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0753-2024
Recall Event ID 93630
510(K)NumberK053153 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductCalibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Code Information GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
FDA Determined
Cause 2		Under Investigation by firm
ActionRandox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " 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. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce108 kits
DistributionUS Nationwide including 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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