FDAFDA · Food and drugs·Recall number Z-0033-2022
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.
Published October 13, 2021 · Recall initiated: July 29, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Sentinel CH SpA
- Distributor
- US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
- Lot
- Lot 00681Y600
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Italy
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