RegWardenFDA facility compliance records
Company

SENTINEL CH. SpA

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2017: 1 recalls; 2019: 1 recalls; 2021: 2 recalls; 2023: 1 recalls12015201612017201812019202022021202212023202420252026
  • Recalls (6)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SENTINEL CH. SpA — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9025279-sentinel-ch-spa/

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