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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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