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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Microalbumin Calibrators Series (mALB CAL)MA1567

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  Class 2 Device Recall Randox Microalbumin Calibrators Series (mALB CAL)MA1567 see related information
Date Initiated by Firm January 31, 2024
Date Posted April 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1593-2024
Recall Event ID 94138
Product Classification Calibrator, secondary - Product Code JIT
Product Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay
Catalog Number: MA1567
Code Information GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories (Manufacturer) issued Urgent Field Safety Notice on 31 Jan 24 Complaint Reference: REC716 letter via email to Distributors. Distributors will contact the end-users. Letter states reason for recall, health risk and action to take: We have reassigned the target values in the above lot numbers in line with the ERM reference material. Please refer to the table below for the updated calibrator targets. You may experience a shift in Quality Control and patient sample recovery of up to +12%. Please discard all copies of the calibrator Instructions For Use (IFU)s and download the updated IFUs from www.randox.com . If further information is required, please contact technical.services@randox.com . In line with the restandardisation to the Microalbumin Calibrator Series, we are updating the target and range for the Microalbumin Liquid control, MA1361, lots 1102MA and 1103MA which are present in batch 631698. The updated targets and ranges can be found in the table below. Please discard any copies of the IFU and download the updated version from www.randox.com.
Quantity in Commerce 8 units
Distribution US Nationwide distribution in the states of GA, MA, WV 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.
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