Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2024, with 4 FDA device recalls on record.
Top product codes for Accelerate Diagnostics, Inc.
FDA recalls by Accelerate Diagnostics, Inc.
- Z-0345-2023 — Accelerate PhenoTest BC kit REF 10101018
- Z-0346-2023 — Accelerate PhenoTest BC kit REF 10102018
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Accelerate Diagnostics, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.