FDA Device recall Z-2307-2012
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 914-7…
- FDA Device
- Class II
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class II recall of 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 914-7… by Princeton Biomeditech, citing there have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2307-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-09 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Princeton Biomeditech |
| Distribution | US |
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
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Identifiers
| code_info | 510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.