# FDA recall Z-0414-2026

> **Cepheid** · Class II · device recall initiated 2025-08-06.

## Product

Xpert SA Nasal Complete  Catalog Number: GXSACOMP-10  UDI-DI code: 07332940000158    Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

## Reason for recall

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

## Distribution

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

## Key facts

- **Recall number:** Z-0414-2026
- **Recalling firm:** Cepheid
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-06
- **Report date:** 2025-11-05

- **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-0414-2026

## Citation

> AI Analytics. FDA recall Z-0414-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0414-2026. Source: US FDA. Licensed CC0.

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