Recall Z-0414-2026 · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cepheid
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
| Date | Oct 30, 2025 (initiated Aug 6, 2025) |
| Status | Open, Classified |
| Reason | As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. |
| Root cause | Under Investigation by firm |
| Action | On 08/21/2025, the firm sent via FedEx an "Urgent Medical Device Recall" to customers to inform customers that Cepheid conducted a routine post-market stability study for GXSACOMP-10 kit batch 1001424179 lot 27815, which failed to meet the half-time stability criteria set for this product. Preliminary investigation indicates that kit batch 1001424181 lot 27816 of the same product may also be impacted. Customers are instructed to: 1. Dispose of GXSACOMP-10 lots 27815 and/or 27816 you have in inventory. Cepheid will provide replacement product. The replacement product should ship within 5 busin |
| Quantity | 4,132 kits |
| 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. |
| FDA record | Open on fda.gov |