Recall Z-1018-2019 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Randox Laboratories Ltd.
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.
| Date | Dec 3, 2018 |
| Status | Open, Classified |
| Reason | 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%. |
| Root cause | 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 yo |
| Quantity | 133 kits |
| Distribution | US Distribution to states to: CA, ME. MI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023763 | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS Randox Laboratories, Ltd., Jan 13, 2003 |