Recall Z-0033-2022— Sentinel CH SpA
Class III · Terminated
Class III FDA medical device recall by Sentinel CH SpA, initiated 2021-07-29, terminated 2023-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Sentinel CH SpA
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-07-29
- Terminated
- 2023-07-24
- Firm location
- Milan, Italy
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.