Boston, MA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | Class II | Microbiology | 1 | 2020-04-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-03-29 | Class II | Ongoing | Z-1626-2023 | binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoe… | — | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce eit… |