Sentinel CH SpA

FDA recalling firm · 6 enforcement events · 8 product records · 2015–2023 · N/A

Sentinel CH SpA has 6 FDA enforcement events on this register (8 product records) between 2015 and 2023: 6 device; the busiest year was 2021 with 2.

0% of its events are Class I; the most common class is Class II (4). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
29 Sep 2023	IRON assay, Reference Numbers 6K95-41 and 6K95-30	Device	Class II	2	Ongoing
29 Jul 2021	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.	Device	Class III	1	Terminated
30 Apr 2021	ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001	Device	Class III	1	Ongoing
28 Jun 2019	MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30	Device	Class II	2	Terminated
22 May 2017	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…	Device	Class II	1	Terminated
22 Sep 2015	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.	Device	Class II	1	Terminated

By type and class

Device6

Class II4

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Sentinel CH SpA by year initiated.

Questions and answers

How many FDA recalls has Sentinel CH SpA had?

6 enforcement events (8 product records) on this register, 2015–2023: 6 device.

Are any Sentinel CH SpA recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Sentinel CH SpA recalls?

4 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.