Sentinel CH SpA Recall 88680
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.
Sentinel CH SpA Recall 88680 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0033-2022 |
| Event ID | 88680 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico. |
| Quantity | 32 |
| Recall 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. |
| Device Classification | 20211013 |
| Device Code Info | Lot 00681Y600 |
| Center Classification Date | 20211006 |
| Recall Initiation Date | 20210729 |
| Recalling Firm | Sentinel CH SpA |
| Similar To |