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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Protein Calibrator

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  Class 2 Device Recall Liquid Protein Calibrator see related information
Date Initiated by Firm March 01, 2024
Date Posted March 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1328-2024
Recall Event ID 94187
510(K)Number K061056  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Code Information Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)
Recalling Firm/
Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information Contact Louise Lynne
Manufacturer Reason
for Recall
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
FDA Determined
Cause 2
Under Investigation by firm
Action Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to technical.services@randox.com within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.
Quantity in Commerce 1,764 units
Distribution Domestic: CA, FL, IL, ME, NJ, OH, & OR.
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 = JIX and Original Applicant = RANDOX LABORATORIES, LTD.