Accelerate Pheno™ System
ACCELERATE DIAGNOSTICS, INC. · Model 10301008 · UDI-DI 00862011000321
Description
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples. Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
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 Staphylococcus aureus and |
| 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 Staphylococcus aureus and |
| 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 by broth microdilut |
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