Cepheid: Device Recall

Recall Details

Recall Number

Z-0414-2026

Classification

Class II

Product Type

Device

Recalling Firm

Cepheid

Status

Ongoing

Date Initiated

08/06/2025

Location

Sunnyvale, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4,132 kits

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Other Recalls by Cepheid

• Class II: Risk 11/05/2025
  Product testing did not meet expected stability criteria.
• Class II: Risk 10/30/2025
  Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
• Class II: Risk 10/30/2025
  Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
• Class II: Risk 06/20/2024
  Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

View all recalls by Cepheid →