Accelerate Diagnostics, Inc.
Tucson, AZ, US
Accelerate Diagnostics, Inc. appears in FDA device records in Tucson, AZ. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Accelerate Diagnostics, Inc. between 2020 and 2024. The busiest year on record is 2020, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2024 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 Staphylococcus aureus and Streptococcus spp. | Class II | Open, Classified | |
| 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 Staphylococcus aureus and Streptococcus spp. | Class II | Open, Classified | |
| Z-1529-2018 | Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system. | The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). | Class II | Terminated | |
| Z-1065-2019 | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain