Princeton Biomeditech Recalls Orasure QuickFlu Rapid A+B Test Kits
Princeton Biomeditech is recalling Orasure QuickFlu Rapid A+B Test kits due to reports of dual positive results for Flu A and Flu B.
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 potential diagnostic errors (dual positive results) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/performance issues.
Plain-English summary
Princeton Biomeditech Corp is recalling the Orasure QuickFlu Rapid A+B Test, an in vitro rapid qualitative test used to detect influenza type A and type B nucleoprotein antigens. The test is intended for professional and laboratory use to aid in the rapid differential diagnosis of influenza A and B viral infections from nasal swab, nasopharyngeal swab, and nasal pharyngeal aspirate/wash specimens.
The recall was initiated because there have been reports of dual positive results, where the test indicated positive for both Flu A and Flu B simultaneously. The affected products include 370 kits of 12 tests each and 2,800 kits of 22 tests each. The products were distributed nationwide, including in New Jersey, New York, and Pennsylvania.
Users of the affected test kits should stop using them and contact Princeton Biomeditech Corp for further instructions. The recall number is Z-2306-2012.
The recalled product
- Product
- Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal…
- Manufacturer
- Princeton Biomeditech Corp
- Hazard
Distribution
Part of a larger recall action
This product is one of 3 recalled by Princeton Biomeditech Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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