Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes

Recalled November 5, 2025 · FDA recall Z-0414-2026 · Cepheid

Hazard

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

Units

4,132 kits

Sold at

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.

Description

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

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

Manufacturer(s)

Cepheid

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →