Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code:… — Class II medical device recall Z-0414-2026
Ongoing recall by Cepheid, reported 2025-11-05, distributed nationwide. As a result of Post-Market half-time stability testing, false negative test result was observed for a positive
| Recall number | Z-0414-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 4,132 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 07332940000158 |
| Lot numbers | 1001424179, 1001424181, 27815, 27816 |
| Model numbers | GXSACOMP-10 |
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
Reason for recall
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0414-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.