Accelerate PhenoTest™ BC Kit 10101018Recalls & reported problems

Accelerate Diagnostics, Inc. · 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. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Oct 17, 2022Open, Classified
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.
Z-0345-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Device details

UDI-DI	`00862011000307`
Brand	Accelerate PhenoTest™ BC Kit
Model	10101018
Company	Accelerate Diagnostics, Inc.
Product code	PRH · Positive Blood Culture Identification And Ast Kit
Class	Class 2
FDA submission	DEN160032
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 21, 2020

Device type (GMDN): Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.

Other Positive Blood Culture Identification And Ast Kit devices

Accelerate PhenoTest® BC kit 10102018
Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit
1 recall1 report
Accelerate Pheno™ System 10401008
Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit
2 reports

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.