Accelerate PhenoTest BC kit recalled for false positive results
Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic accuracy (false positives) rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Accelerate Diagnostics Inc is recalling 95 units of the Accelerate PhenoTest BC kit, Reference #10101018. The affected lots are 2880A, 2885A, 2886A, and 2887A, all with an expiration date of 9/18/2018. The kits are multiplexed in-vitro diagnostic tests intended for use with the Accelerate Pheno system.
The recall was initiated because the kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). This issue could lead to incorrect identification of the bacteria in patient samples.
The affected products were distributed to Illinois, Texas, California, South Carolina, and Delaware. Users of the Accelerate Pheno system should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
- Manufacturer
- Accelerate Diagnostics Inc
- Hazard
- Affected units
- 95
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers 2880A
- 2885A
- 2886A
- and 2887A
- all with exp. date of 9/18/2018.
Distribution
Related recalls
Same manufacturer · Accelerate Diagnostics Inc
See all →- HighAccelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification
FDA (Devices) · 2022-12-07
- HighDiagnostic Kit Recalled for False Positive Bacterial Identification Results
FDA (Devices) · 2022-12-07
- HighAccelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results
FDA (Devices) · 2019-04-03
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11