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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 3see related information
Date Initiated by FirmMay 04, 2023
Date PostedJune 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2021-2023
Recall Event ID 92344
510(K)NumberK140522 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductImmunoassay 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
ActionRandox 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 Commerce1 kit
DistributionCA, IL, VA, WA, WI 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 = JJY
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