Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit
FDA device recall Z-0414-2026 · posted 2025-10-30 · Open, Classified
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NQX
- Quantity affected
- 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,
- Date initiated
- 2025-08-06
- Date posted
- 2025-10-30
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Xpert® SA Nasal Complete (K243070) | Cepheid® | 2024-10-25 |
| XPERT MRSA/SA NASAL ASSAY (K100822) | Cepheid | 2010-06-01 |