Accelerate PhenoTest® BC kit 10102018Recalls & 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
All models of Accelerate PhenoTest BC Kit (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00862011000369), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “False Positive Result” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0346-2023 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT THE ACCELERATE PHENOTEST BC KIT ALLEGEDLY HAD AN INCORRECT RESULT OF METHICILLIN-RESISTANT S. AUREUS (MRSA) AND THE PATIENT'S CENTRAL LINE WAS REMOVED AND A NEW CENTRAL LINE WAS INSERTED. THE CUSTOMER STATED THAT TESTING ON THE BD PHOENIX IDENTIFIED S. EPIDERMIDIS. THE INCORRECT RESULT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820984 ↗
Other Positive Blood Culture Identification And Ast Kit devices
- Accelerate PhenoTest™ BC Kit 10101018Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit1 recall0 reports
- Accelerate Pheno™ System 10401008Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page