Recall Z-0164-2016 ยท JIF Enzymatic Method, Ammonia
Sentinel CH SpA
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
| Date | Oct 26, 2015 (initiated Sep 22, 2015) |
| Status | Terminated |
| Reason | Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. |
| Root cause | Process control |
| Action | Sentinel Urgent Field Safety Notice issued on 9/22/15 by Abbott to customers, including their US customers. Actions to be Taken 1. Immediately discontinue use of lot 50083Y600 and destroy any remaining inventory. 2. Order a replacement Ammonia Ultra reagent lot. 3. Follow your individual laboratory protocol regarding reviewing previously reported patient results. 4. Please retain this communication for future reference. If you have forwarded any MULTIGENT Ammonia Ultra reagent lot 50083Y600 to another laboratory, please provide a copy of this letter to them. Contacts If you or any of the heal |
| Quantity | 765 kits |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY Sentinel Ch. Srl, Nov 25, 2005 |