Sentinel CH SpA
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 22
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0326-2024 | Class II | Alinity c Iron Reagent, Reference Number 08P3920 | September 29, 2023 |
| Z-0325-2024 | Class II | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | September 29, 2023 |
| Z-0033-2022 | Class III | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in th | July 29, 2021 |
| Z-2012-2021 | Class III | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzym | April 30, 2021 |
| Z-2551-2019 | Class II | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively th | June 28, 2019 |
| Z-2552-2019 | Class II | Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using res | June 28, 2019 |
| Z-2867-2017 | Class II | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quanti | May 22, 2017 |
| Z-0164-2016 | Class II | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: | September 22, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242585 | Cystatin C | May 16, 2025 |
| K211058 | Lp(a) Ultra | December 22, 2022 |
| K193001 | Albumin BCP | December 19, 2019 |
| K192118 | CRP Vario | November 8, 2019 |
| K173833 | CRP Vario | September 27, 2018 |
| K141728 | ACE CALIBRATOR | July 28, 2014 |
| K102706 | CKMB UDR ASSAY | August 19, 2011 |
| K083602 | KAPPA LIGHT CHAINS | September 3, 2009 |
| K083601 | LAMBDA LIGHT CHAINS | June 22, 2009 |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | June 25, 2008 |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | June 19, 2008 |
| K070987 | SENTINEL LITHIUM ASSAY | August 2, 2007 |
| K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL | May 23, 2007 |
| K051447 | SENTINEL PANCREATIC AMYLASE | January 26, 2006 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | November 25, 2005 |
| K051111 | SENTINEL UIBC LIQUID | November 17, 2005 |
| K051452 | SENTINEL CLIN CHEM CAL | October 25, 2005 |
| K051456 | SENTINEL CERULOPLASMIN | October 21, 2005 |
| K051115 | SENTINEL IRON LIQUID | August 25, 2005 |
| K050836 | CRP DIAGNOSTIC ASSAY | August 8, 2005 |