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 | Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. |
| Product | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials … |
| Quantity | 2356 kits Worldwide; US 206 kits |
| Distribution | Nationwide Distribution |
| Initiated | 2017-05-22 |
| Classified | 2017-08-03 |
| Terminated | 2018-09-04 |
| Recall number | Z-2867-2017 |
| 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-2867-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77405/
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