Sentinel CH SpA Recall: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 0
Sentinel CH SpA Recall: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 0 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sentinel CH SpA; Product: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the
| Recalling firm | Sentinel CH SpA |
|---|---|
| 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 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. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico. |
| Recall initiated | 20210729 |
| Recall number | Z-0033-2022 |
| Category | device |
| Country | Italy |
$29/mo
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