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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Detail

Product Description 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 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.
Recall Number Z-2308-2012
Classification Class II
Code Info 510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)
Product Distributed Qty 90 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.