FDA Device recall Z-0164-2016
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement by Sentinel Ch Spa, citing results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0164-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-22 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sentinel Ch Spa |
| Distribution | US |
Product
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.
Reason
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Identifiers
| code_info | Lot 50083Y600, expiration date 31 Jul 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0164-2016%22
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