SENTINEL CH. SpA
Medical device manufacturer in Milan (Mi), IT.
22510(k) clearances
0PMA approvals
8recalls
Device types
- JIX Calibrator, Multi-Analyte Mixture 4
- DCK C-Reactive Protein, Antigen, Antiserum, And… 2
- NDY Test, Cystatin C 1
- DIH Colorimetry, Cholinesterase 1
- DFC Lipoprotein, Low-Density, Antigen… 1
- CJW Bromcresol Purple Dye-Binding, Albumin 1
- NQD Cardiac C-Reactive Protein, Antigen… 1
- JIT Calibrator, Secondary 1
- JHS Differential Rate Kinetic Method, Cpk Or… 1
- DFH Kappa, Antigen, Antiserum, Control 1
- DEH Lambda, Antigen, Antiserum, Control 1
- JFY Enzymatic Method, Creatinine 1
- NDW Assay, Porphyrin, Spectrophotometry, Lithium 1
- JFJ Catalytic Methods, Amylase 1
- JIF Enzymatic Method, Ammonia 1
- JQF Bathophenanthroline, Iron Binding Capacity 1
- JFR Indirect Copper Assay, Ceruloplasmin 1
- JIY Photometric Method, Iron (Non-Heme) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242585 | Cystatin CNDY · Traditional | 05/16/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | 12/22/2022SE |
| K193001 | Albumin BCPCJW · Traditional | 12/19/2019SE |
| K192118 | CRP VarioDCK · Special | 11/08/2019SE |
| K173833 | CRP VarioNQD · Traditional | 09/27/2018SE |
| K141728 | Ace CalibratorJIT · Abbreviated | 07/28/2014SE |
| K102706 | CKMB Udr AssayJHS · Traditional | 08/19/2011SE |
| K083602 | Kappa Light ChainsDFH · Traditional | 09/03/2009SE |
| K083601 | Lambda Light ChainsDEH · Traditional | 06/22/2009SE |
| K081533 | Sentinel Plasmaproteins Cal 3XJIX · Traditional | 06/25/2008SE |
| K073634 | Multigent Creatinine (Enzymatic) AssayJFY · Traditional | 06/19/2008SE |
| K070987 | Sentinel Lithium AssayNDW · Traditional | 08/02/2007SE |
| K070971 | Modification to Sentinel Clin Chem CalJIX · Traditional | 05/23/2007SE |
| K051447 | Sentinel Pancreatic AmylaseJFJ · Traditional | 01/26/2006SE |
| K051114 | Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional | 11/25/2005SE |
| K051111 | Sentinel Uibc LiquidJQF · Traditional | 11/17/2005SE |
| K051452 | Sentinel Clin Chem CalJIX · Abbreviated | 10/25/2005SE |
| K051456 | Sentinel CeruloplasminJFR · Traditional | 10/21/2005SE |
| K051115 | Sentinel Iron LiquidJIY · Traditional | 08/25/2005SE |
| K050836 | CRP Diagnostic AssayDCK · Traditional | 08/08/2005SE |
| K051457 | Sentinel Plasmaproteins Cal 3XJIX · Abbreviated | 07/25/2005SE |
| K051444 | Sentinel Cholinesterase LiquidDIH · Special | 06/20/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0326-2024 Class II | Alinity c Iron Reagent, Reference Number 08P3920A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the… | 09/29/2023Open, Classified |
| Z-0325-2024 Class II | IRON assay, Reference Numbers 6K95-41 and 6K95-30A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the… | 09/29/2023Open, Classified |
| Z-0033-2022 Class III | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product…Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to… | 07/29/2021Terminated |
| Z-2012-2021 Class III | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin…Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New… | 04/30/2021Open, Classified |
| Z-2552-2019 Class II | Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or…Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number… | 06/28/2019Terminated |
| Z-2551-2019 Class II | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using…Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number… | 06/28/2019Terminated |
| Z-2867-2017 Class II | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for…Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not… | 05/22/2017Terminated |
| Z-0164-2016 Class II | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement…Results for ammonia are below the linear range of the assay for samples that have been collected in sodium… | 09/22/2015Terminated |