Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Accelerate Diagnostics with 4 device recalls, 2 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Sep 26, 2024: Accelerate Arc System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 26, 2024 | Accelerate Arc SystemK240854 · QNJ | 510(k) clearances |
| Oct 17, 2022 | Accelerate PhenoTest BC kit REF 10101018Class II · Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false p | Device recalls |
| Oct 17, 2022 | Accelerate PhenoTest BC kit REF 10102018Class II · Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false p | Device recalls |
| Sep 15, 2020 | Accelerate Pheno System, Accelerate PhenoTest BC KitK192665 · PRH | 510(k) clearances |
| Sep 15, 2020 | Accelerate Pheno System, Accelerate PhenoTest BC KitK192665 · Microbiology | AI-enabled devices |
| Mar 14, 2018 | Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diaClass II · The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). | Device recalls |
| Mar 13, 2017 | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is iClass II · Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using th | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
