Class II — Princeton Biomeditech Corp
| Recalling firm | PRINCETON BIOMEDITECH CORP. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Product | Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 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 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… |
| Quantity | 90 kits (22 tests per kit) |
| Distribution | Nationwide Distribution-including the states of NJ, NY, and PA. |
| Initiated | 2012-03-09 |
| Classified | 2012-08-31 |
| Terminated | 2014-10-14 |
| Recall number | Z-2308-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Princeton Biomeditech Corp (Z-2308-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62537/
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