Accelerate PhenoTest BC KitRecalls & reported problems across all models
Accelerate Diagnostics, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Accelerate PhenoTest BC Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 2 models of Accelerate PhenoTest BC Kit by Accelerate Diagnostics, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Accelerate PhenoTest BC Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 ↗
- 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 · Recall details · FDA record ↗
Most reported Accelerate PhenoTest BC Kit problems
Device problems
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Accelerate PhenoTest BC Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accelerate PhenoTest® BC kit 10102018Positive Blood Culture Identification And Ast Kit1 recall1 report
- Accelerate PhenoTest™ BC Kit 10101018Positive Blood Culture Identification And Ast Kit1 recall0 reports
Recent Accelerate PhenoTest BC Kit adverse event reports
The 1 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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