Home › Device types › PRH
Positive Blood Culture Identification And Ast Kit
FDA product code PRH · Class 2 · Microbiology
8
Registered devices
4
Adverse events
4
Recalls
2
510(k) clearances
Devices with this code
Accelerate Pheno™ System — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest™ BC Kit — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest BC ID QC test — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest BC AST QC test — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest BC kit — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest® BC kit — ACCELERATE DIAGNOSTICS, INC.Accelerate PhenoTest® BC AST QC test — ACCELERATE DIAGNOSTICS, INC.Accelerate Pheno™ System — ACCELERATE DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-17 | Accelerate Diagnostics Inc | 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 | Accelerate Diagnostics Inc | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staph |
| 2018-03-14 | Accelerate Diagnostics Inc | The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). |
| 2017-03-13 | Accelerate Diagnostics Inc | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result |
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