# FDA recall Z-0196-2022

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2021-09-22.

## Product

ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

## Reason for recall

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

## Distribution

US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.

## Key facts

- **Recall number:** Z-0196-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-22
- **Report date:** 2021-11-10
- **Termination date:** 2022-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0196-2022

## Citation

> AI Analytics. FDA recall Z-0196-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0196-2022. Source: US FDA. Licensed CC0.

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