Facility

SENTINEL CH. SPA

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3000303338
Establishment type	Repack or Relabel Medical Device
Location	VIA ROBERT KOCH, 2 MILANO, IT 20152
Registration status	Active · expires 2026
Parent company	SENTINEL CH. SpA (owner-operator 9025279)
Brand names	ACE Control Set

Activity by year

Recalls (6)
Inspections (2)

Devices registered here (1)

Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

Recalls & enforcement

Class IIOngoing2023-09-29
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to …
Class IIITerminated2021-07-29
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
Class IIIOngoing2021-04-30
Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.
Class IITerminated2019-06-28
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient …
Class IITerminated2017-05-22
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Class IITerminated2015-09-22
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

FDA inspections (2)

NAI2018-02-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices
NAI2016-09-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by SENTINEL CH. SpA

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SENTINEL CH. SPA (FEI 3000303338) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000303338-sentinel-ch-spa/

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