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U.S. Department of Health and Human Services

Class 3 Device Recall Randox Immunoassay Premium Level 3

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  Class 3 Device Recall Randox Immunoassay Premium Level 3 see related information
Date Initiated by Firm May 04, 2023
Date Posted June 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2021-2023
Recall Event ID 92344
510(K)Number K140522  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.
Catalog Number: IA2640
Code Information GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Randox issued via email to the Distributor Medical Device Correction Letter and forwarded to US and PR customers on 04 May, 2023. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the current IFU and download the updated IFU from randox.com Discuss the contents of this notice with your Medical Director. Complete and return the response for 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 organization. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce 1 kit
Distribution CA, IL, VA, WA, WI including PR
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 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) Database 510(K)s with Product Code = JJY and Original Applicant = RANDOX LABORATORIES LIMITED
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