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.
Reported: October 13, 2021 Initiated: July 29, 2021 #Z-0033-2022
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.
Details
- Recalling Firm
- Sentinel CH SpA
- Units Affected
- 32
- Distribution
- US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
- Location
- Milan
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sentinel CH SpA. Units affected: 32.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Low. Recall number: Z-0033-2022.
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