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Accelerate PhenoTest™ BC Kit

ACCELERATE DIAGNOSTICS, INC. · Model 10101018 · UDI-DI 00862011000307

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510(k) clearances

Adverse events

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Description

The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods 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 followed by susceptibility testing of the appropriate detected bacterial organisms. 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.