Sentinel CH SpA FDA Recalls

4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Alinity c Iron Reagent, Reference Number 08P3920Class IISep 29, 2023A high recovery of Iron assay has been observed at some cust	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positi	Class IIDevices	Sep 29, 2023
IRON assay, Reference Numbers 6K95-41 and 6K95-30Class IISep 29, 2023A high recovery of Iron assay has been observed at some cust	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positi	Class IIDevices	Sep 29, 2023
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of theClass IIIJul 29, 2021Calibrator vials were incorrectly labeled. Use of incorrectl	Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to gener	Class IIIDevices	Jul 29, 2021
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 16670Class IIIApr 30, 2021Claim for stability after reconstitution from lyophilized to	Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. Ne	Class IIIDevices	Apr 30, 2021