# FDA recall Z-0033-2022

> **Sentinel CH SpA** · Class III · device recall initiated 2021-07-29.

## 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.

## Distribution

US Nationwide distribution in the states of LA, MD, MN, ND, NY, WV, and Puerto Rico.

## Key facts

- **Recall number:** Z-0033-2022
- **Recalling firm:** Sentinel CH SpA
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-29
- **Report date:** 2021-10-13
- **Termination date:** 2023-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2022

## Citation

> AI Analytics. FDA recall Z-0033-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0033-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*