Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | 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 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. |
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| Recall Number | Z-2306-2012 |
| Classification | Class II |
| Code Info | 510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits |
| Product Distributed Qty | 370 (12 tests per kit) ;2800 kits (22 tests per kit) |
| Reason For Recall | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
Event Detail
| Event Id | 62537 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Princeton Biomeditech Corp |
| City | Monmouth Junction |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including the states of NJ, NY, and PA. |
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