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U.S. Department of Health and Human Services

Class 2 Device Recall Fructosamine Calibrator

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  Class 2 Device Recall Fructosamine Calibrator see related information
Date Initiated by Firm December 03, 2018
Create Date March 15, 2019
Recall Status1 Open3, Classified
Recall Number Z-1016-2019
Recall Event ID 81783
510(K)Number K023763  
Product Classification Calibrator, secondary - Product Code JIT
Product Fructosamine Calibrator, FR2993

This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Code Information 498FR
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Randox, notified the US distributor via email on 3 Dec 2018 with an "Urgent Medical Device Correction" letter dated 26 Nov 2018. The distributors and customers were instructed to remove the Value Sheet from existing stock and replace with the new Value Sheet and Important Notice. Customers were asked to take the following actions: " Please review all remaining stock and add the attached important notice to each kit. Replace the kit value sheet with the revised document provided. " Discuss the contents of this notice with your Medical Director. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services by email: maria.kelly@randox.com or +44 (0)28 9442 2413 or Tel: +1 304 728 2890 Toll Free 866 4 RANDOX or Email: Cheryl.O'Hagan@randox.com.
Quantity in Commerce 85 kits
Distribution US Distribution to states to: CA, ME. MI, and WV.
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 = JIT and Original Applicant = RANDOX LABORATORIES, LTD.
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