Princeton Biomeditech Recalls Poly stat Flu A & B Test Kits
Princeton Biomeditech Corp is recalling 103 kits of the Poly stat Flu A & B Test due to reports of dual positive results.
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 potential diagnostic errors (dual positive results) without reported injuries or illnesses, fitting the criteria for moderate severity involving low-risk contamination or minor labeling/performance issues.
Plain-English summary
Princeton Biomeditech Corp is recalling 103 kits (22 tests per kit) of the Poly stat Flu A & B Test, manufactured for Polymedco. The product is an in vitro rapid qualitative test intended to detect influenza type A and type B nucleoprotein antigens from nasal swabs, nasopharyngeal swabs, and nasal pharyngeal aspirate/wash specimens. The test is intended for professional and laboratory use to aid in the rapid differential diagnosis of influenza A and B viral infections.
The recall was initiated due to reports of dual positive (Flu A + Flu B positive) results being encountered. The affected products are identified by Catalog Number FLU22 and Lot numbers 441A11 and 441C11. The 510(k) number for the device is K083746.
The recalled products were distributed nationwide, including the states of New Jersey, New York, and Pennsylvania. Users should stop using the affected test kits and contact the recalling firm for further instructions.
The recalled product
- Product
- Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucle
- Manufacturer
- Princeton Biomeditech Corp
- Hazard
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 (2)
- 510 k K083746 Catalog Number FLU22 Lot numbers 441A11
- 441C11
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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