Sentinel CH SpA recalls

Sentinel CH SpA has 8 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 29 Nov 2023. 3 are still ongoing. The most frequent reason is potency & assay.

Total recalls8since 2015

Last 12 months0reported

Class I00% of total

Ongoing3latest 29 Nov 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 75%Class III 2 25%

Why sentinel ch spa is recalled

Product types

Test Kits & Diagnostics788%
Other Medical Devices113%

By year

2023225%
2021225%
2019225%
2017113%
2015113%

Ongoing sentinel ch spa recalls

3 active

Reported	Class	Recall	Company	Reason	Where
29 Nov 2023Device	CLASS II	Alinity c Iron Reagent, Reference Number 08P3920 recalled	Sentinel CH SpA	Potency & Assay	Nationwide
29 Nov 2023Device	CLASS II	IRON assay, Reference Numbers 6K95-41 and 6K95 recalled	Sentinel CH SpA	Potency & Assay	Nationwide
14 Jul 2021Device	CLASS III	ACE Control Set - IVD Control set recalled by Sentinel CH SpA	Sentinel CH SpA	Potency & Assay	Nationwide

All sentinel ch spa recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
29 Nov 2023Device	CLASS II	Alinity c Iron Reagent, Reference Number 08P3920 recalled	Sentinel CH SpA	Potency & Assay	Nationwide
29 Nov 2023Device	CLASS II	IRON assay, Reference Numbers 6K95-41 and 6K95 recalled	Sentinel CH SpA	Potency & Assay	Nationwide
13 Oct 2021Device	CLASS III	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit recalled	Sentinel CH SpA	Labeling Errors	Nationwide
14 Jul 2021Device	CLASS III	ACE Control Set - IVD Control set recalled by Sentinel CH SpA	Sentinel CH SpA	Potency & Assay	Nationwide
2 Oct 2019Device	CLASS II	Alinity c Lithium Reagent Kit- intended recalled by Sentinel CH SpA	Sentinel CH SpA	Other	Nationwide
2 Oct 2019Device	CLASS II	Multigent Lithium-intended for the quantitation of lithium recalled	Sentinel CH SpA	Other	Nationwide
9 Aug 2017Device	CLASS II	Multigent Creatinine (Enzymatic) recalled by Sentinel CH SPA	Sentinel CH SPA	Other	Nationwide
4 Nov 2015Device	CLASS II	Sentinel Multigent Ammonia Ultra Reagent recalled by Sentinel CH SpA	Sentinel CH SpA	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.