Tucson, AZ, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QNJ | Mass Spectrometry, Microorganism Identification, Blood Culture | Class II | Microbiology | 1 | 2024-09-26 |
| PRH | Positive Blood Culture Identification And Ast Kit | Class II | Microbiology | 1 | 2020-09-15 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-10-17 | Class II | Ongoing | Z-0346-2023 | Accelerate PhenoTest BC kit REF 10102018 | — | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staph… |
| 2022-10-17 | Class II | Ongoing | Z-0345-2023 | Accelerate PhenoTest BC kit REF 10101018 | — | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staph… |