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U.S. Department of Health and Human Services

Class 2 Device Recall Randox

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  Class 2 Device Recall Randox see related information
Date Initiated by Firm November 22, 2022
Date Posted January 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-0903-2023
Recall Event ID 91225
510(K)Number K972608  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2682
Control Level 1
Code Information GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. 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. 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.
Quantity in Commerce 146 units US
Distribution US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
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, LTD.
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