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Sign in to claim this brandAccelerate Diagnostics, Inc.
US
Last updated May 30, 2026
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 186328670
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accelerate Pheno™ System | 10301008 | FDA UDI | Class II | Active |
| Accelerate PhenoTest® BC AST QC test | 10107158 | FDA UDI | Class II | Active |
| Accelerate PhenoTest BC ID QC test | 10105158 | FDA UDI | Class II | Active |
| Accelerate PhenoTest™ BC Kit | 10101018 | FDA UDI | Class II | Active |
| Accelerate Pheno™ System | 10401008 | FDA UDI | Class II | Active |
| Accelerate PhenoTest BC kit | 10104018 | FDA UDI | Class II | Active |
| Accelerate PhenoTest® BC kit | 10102018 | FDA UDI | Class II | Active |
| Accelerate PhenoTest BC AST QC test | 10106158 | FDA UDI | Class II | Active |
| Accelerate Pheno System, Accelerate PhenoTest BC Kit | K192665 | FDA 510(k) | Class II | Active |
| Accelerate Arc System | K240854 | FDA 510(k) | Class II | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 17, 2022 | Z-0345-2023 | — | open, classified | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp. |
| Oct 17, 2022 | Z-0346-2023 | — | open, classified | Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp. |
| Mar 14, 2018 | Z-1529-2018 | — | terminated | The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). |
| Mar 13, 2017 | Z-1065-2019 | — | terminated | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results. |