# FDA recall Z-0216-2024

> **Cepheid** · Class II · device recall initiated 2023-04-24.

## Product

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

## Reason for recall

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test  results.

## Distribution

Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

## Key facts

- **Recall number:** Z-0216-2024
- **Recalling firm:** Cepheid
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-24
- **Report date:** 2023-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0216-2024

## Citation

> AI Analytics. FDA recall Z-0216-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0216-2024. Source: US FDA. Licensed CC0.

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