Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xp…

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

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

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 business days following receipt of the completed response form. 2. If you have previously received or receive a negative test result with GXSACOMP-10 lots 27815 or 27816, and the patient shows clinical signs/symptoms of SA or MRSA, re-test with a cartridge from a different lot or use an alternative test/method for SA or MRSA, if available. 3. With all questionable positive or questionable negative results, please continue to report to Cepheid Technical Support for investigation. 4. Cepheid asks that you acknowledge receipt of this Urgent Medical Device Recall by completing the attached Customer Response Form and either emailing the completed form to CFQ@cepheid.com or faxing it to +1 (408) 716-3143. Cepheid will not send a reply or confirmation of received response forms.

• FDA enforcement recordOfficial FDA database entry for Z-0414-2026
• FDA 510(k) clearance · K100822The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243070The device's official FDA premarket clearance record
• FDA device classification · NQXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CepheidSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.