Quidel Recalls Influenza Transport Swab Packages Due to Incorrect Swabs
Quidel Corporation is recalling Influenza Transport Swab Packages because they may contain incorrect sample swabs mixed with the proper ones.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential mix-up of swabs without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Quidel Corporation is recalling Influenza Transport Swab Packages, Reference #20171, because the packages may include an incorrect sample swab mixed in with the proper swabs. The recalled product consists of one lot containing 1,010 packages, with each package containing 25 transport tubes. These swabs in dry transport tubes are intended for use with influenza tests.
The recall is due to the potential presence of incorrect sample swabs within the packages. The source text does not specify the nature of the incorrect swabs or the specific risks associated with their use.
The products were distributed nationwide to Florida, Georgia, Illinois, Indiana, Kentucky, Montana, Ohio, Pennsylvania, and Texas. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests
- Manufacturer
- Quidel Corporation
- Hazard
- Affected units
- 1,010
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 (1)
- PS10171
Distribution
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