Device 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.
Z-0033-2022
Product summary
- Firm
- Sentinel CH SpA
- Event
- Event 88680
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32
- Official record key
device-enforcement:Z-0033-2022
Official wording
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.
Code information: Lot 00681Y600
Distribution pattern: US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.
Derived failure modes
-
Labeling or packaging
incorrectly labeled