Sunnyvale, CA, US · 11 510(k) clearances · 7 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PQA | — | — | — | 3 | 2023-10-19 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | Class I | Microbiology | 2 | 2023-09-27 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | Class II | Immunology | 1 | 2026-08-07 |
| — | — | — | — | 1 | 2026-02-20 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | Class II | Microbiology | 1 | 2026-01-16 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | Class II | Hematology | 1 | 2025-02-21 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 1 | 2025-01-10 |
| SBP | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | Class II | Microbiology | 1 | 2024-06-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-11-05 | Class II | Ongoing | Z-0724-2026 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | — | Product testing did not meet expected stability criteria. |
| 2025-10-30 | Class II | Ongoing | Z-0960-2026 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | — | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| 2025-10-30 | Class II | Ongoing | Z-0959-2026 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | — | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| 2025-08-06 | Class II | Ongoing | Z-0414-2026 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes… | — | As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. |
| 2024-06-20 | Class II | Ongoing | Z-2584-2024 | Cepheid, Sample Collection Device, Part: 900-0370 | — | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross conta… |
| 2023-04-24 | Class II | Ongoing | Z-0216-2024 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | — | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| 2023-04-24 | Class II | Ongoing | Z-0215-2024 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | — | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-07 | K261362 | Xpert Hemorrhagic Fever | QVR | Class II | Immunology |
| 2026-02-20 | K253653 | Xpert Hemorrhagic Fever | — | — | — |
| 2026-01-16 | K251721 | Xpert GI Panel | PCH | Class II | Microbiology |
| 2025-02-21 | K250218 | Xpert® FII & FV | NPR | Class II | Hematology |
| 2025-01-10 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Class II | Microbiology |
| 2024-06-27 | DEN240016 | Xpert HCV; GeneXpert Xpress System | SBP | Class II | Microbiology |
| 2023-10-19 | K231381 | Xpert Xpress MVP; GeneXpert Xpress System | PQA | — | — |
| 2023-09-27 | K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | NJR | Class I | Microbiology |
| 2022-06-07 | K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | — | — |
| 2022-05-09 | K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | NJR | Class I | Microbiology |
| 2022-02-09 | K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | — | — |