Class II — Sentinel CH SpA
| Recalling firm | SENTINEL CH. SpA |
|---|---|
| Registered facility | SENTINEL CH. SPA (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 765 kits |
| Distribution | Nationwide Distribution. |
| Initiated | 2015-09-22 |
| Classified | 2015-10-26 |
| Terminated | 2016-03-30 |
| Recall number | Z-0164-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sentinel CH SpA (Z-0164-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72311/
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