Food, drugs, devices › Cepheid
Device recall: Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (R
FDA enforcement event 78177 is a device recall by Cepheid of Sunnyvale, CA, initiated 15 Sep 2017 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 28 Jul 2023. 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
"Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert."
Distribution
"USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0028-2018 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis. | 977 kits (9770 units) | Class II | Terminated | 25 Oct 2017 |
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 |
| 6 Aug 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit | Device | Class II | 1 |
| 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 |
| 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: "Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert."
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: "USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Jul 2023. "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.