Sentinel MULTIGENT Ammonia Ultra Reagent — Class II medical device recall Z-0164-2016
Terminated recall by Sentinel CH SpA, reported 2015-11-04, distributed nationwide. Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or
| Recall number | Z-0164-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SpA, Milano, N/A, Italy |
| Recall initiated | 2015-09-22 |
| Classified | 2015-10-26 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 765 kits |
| Reason classes | potency |
| Lot numbers | 50083Y600 |
| Expiration dates | 2016-07-31 |
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 for recall
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0164-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.