Recall Z-0660-2019 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
| Date | Nov 19, 2018 |
| Status | Terminated |
| Reason | Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. |
| Root cause | Under Investigation by firm |
| Action | On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to |
| Quantity | 250 kits (32 kits US / 218 kits OUS) |
| Distribution | US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031608 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., Aug 8, 2003 |