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

Recall date

August 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0414-2026

FDA classification

Class II

Brand / firm

Cepheid

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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