Accelerate PhenoTest BC kit
ACCELERATE DIAGNOSTICS, INC. · Model 10104018 · UDI-DI 00862011000383
Description
The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
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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