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Sentinel CH SpA Recalls
8 recalls on record · November 4, 2015 to November 29, 2023 · Medical Devices
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 29, 2023Medical DevicesFDA
Sentinel CH SpA recalls Alinity c Iron Reagent, Reference Number 08P3920
Hazard: 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 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
November 29, 2023Medical DevicesFDA
Sentinel CH SpA recalls IRON assay, Reference Numbers 6K95-41 and 6K95-30
Hazard: 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 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
October 13, 2021Medical DevicesFDA
Sentinel CH SpA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the
Hazard: 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.
July 14, 2021Medical DevicesFDA
Sentinel CH SpA recalls ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 16670
Hazard: 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.
October 2, 2019Medical DevicesFDA
Sentinel CH SpA recalls Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHIT
Hazard: 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 results
October 2, 2019Medical DevicesFDA
Sentinel CH SpA recalls MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c System
Hazard: 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 results
August 9, 2017Medical DevicesFDA
Sentinel CH SPA recalls MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination
Hazard: Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
November 4, 2015Medical DevicesFDA
Sentinel CH SpA recalls Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended
Hazard: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.