Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit — Class III medical device recall Z-0033-2022
Terminated recall by Sentinel CH SpA, reported 2021-10-13, distributed nationwide. Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to gener
| Recall number | Z-0033-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SpA, Milan, Italy |
| Recall initiated | 2021-07-29 |
| Classified | 2021-10-06 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2023-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 32 |
| Reason classes | labeling |
| Lot numbers | 00681Y600 |
| Model numbers | 07P5605 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0033-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.