Recall Z-2965-2020 ยท JIF Enzymatic Method, Ammonia
RANDOX LABORATORIES, LTD.
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
| Date | Jul 30, 2020 |
| Status | Terminated |
| Reason | Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples. |
| Root cause | Under Investigation by firm |
| Action | The firm, Randox Laboratories Ltd., sent an "Urgent Medical Device Correction" letter dated 30th July 2020 to it customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: - Discontinue use of, quarantine and discard any stock of AM1015, batch 517541 and AM1054, batch 512103 immediately. - Review results generated with the affected batches in line with the clinical profile of the patient. - Discuss the contents of this notice with your Medical Director. -Review your reagent inventory of these products and assess your labor |
| Quantity | 143 kits in total |
| Distribution | US Distribution to states of: VA, UT, WV and country of : Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030873 | RANDOX AMMONIA Randox Laboratories, Ltd., May 12, 2003 |