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U.S. Department of Health and Human Services

Class 2 Device Recall Cystatin C Calibrator

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  Class 2 Device Recall Cystatin C Calibrator see related information
Date Initiated by Firm February 14, 2024
Date Posted March 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1369-2024
Recall Event ID 94088
Product Classification Test, cystatin c - Product Code NDY
Product Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers
Catalog Number: CVS 2699
Code Information GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories Ltd, UK ( manufacturer) notified the US Distributor Randox Laboratories USA . The distributor initial contact and the follow up contact via email on 2/20/24. Letter states reason for recall, health risk and action to take: We have realigned the target values in the above lot numbers to the IFCC Reference Standard. Please refer to the table below for the updated calibrator targets. You may experience a positive shift in Quality Control and patient sample recovery. If you are using CVS 2699 batch 600957 lots 1378CY-1382CY please provide proof of scrappage and a replacement calibrator lot will be provided. 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 realignment to the Cystatin C Calibrator Series, we are updating the target and range for the Cystatin C controls, CYS5019 and CYS5020. The updated target and range 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 666 units
Distribution US Nationwide distribution in the states of CA, IN.
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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