Food, drugs, devices › Cepheid
Device recall: Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit
FDA enforcement event 97497 is a device recall by Cepheid of Sunnyvale, CA, initiated 6 Aug 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cepheid has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cepheid, Sunnyvale, CA.
Reason for recall
"As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0414-2026 | 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… | 4,132 kits | Class II | Ongoing | 5 Nov 2025 |
Context
Other enforcement events for Cepheid
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Nov 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Device | Class II | 1 |
| 30 Oct 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Device | Class II | 2 |
| 20 Jun 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Device | Class II | 1 |
| 24 Apr 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | Device | Class II | 2 |
| 9 Oct 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 10000561 | Device | Class II | 1 |
| 15 Sep 2017 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (R | Device | Class II | 1 |
| 18 Jul 2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System ( | Device | Class II | 1 |
| 27 Jul 2015 | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert C | Device | Class III | 2 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.