Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Recall
- Recall Number
- Z-1018-2019
- Event Number
- 81783
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- JJX
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 3, 2018
Description
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
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%.
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 [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services by email: [email protected] or +44 (0)28 9442 2413 or Tel: +1 304 728 2890 Toll Free 866 4 RANDOX or Email: Cheryl.O'[email protected].
US Distribution to states to: CA, ME. MI, and WV.
133 kits