Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock… — Class II medical device recall Z-2307-2012
Terminated recall by Princeton Biomeditech Corp, reported 2012-09-12, distributed nationwide. There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
| Recall number | Z-2307-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Princeton Biomeditech Corp, Monmouth Junction, NJ, United States |
| Recall initiated | 2012-03-09 |
| Classified | 2012-08-31 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2014-10-14 |
| Distributed | Nationwide (US) |
| Lot numbers | 441A11, 441C11 |
| Model numbers | FLU22 |
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 nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Reason for recall
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2307-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.