FDA Medical devices recall ·
Xpert SA Nasal Complete recall
- Recall number
- Z-0414-2026
- Date
- (initiated August 6, 2025)
- Company / brand
- Cepheid
904 E Caribbean Dr, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,132 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina New Hampshire New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0414-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.