Princeton Biomeditech Corp: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

Agency Publication Date: August 31, 2012

Affected Products

Product: 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 ne

510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits

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 dif

510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11

Lot Numbers:

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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 infection

510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62537

Status: Resolved

Manufacturer: Princeton Biomeditech Corp

Manufactured In: United States

Units Affected: 3 products (370 (12 tests per kit) ;2800 kits (22 tests per kit); 103 kits (22 tests per kit); 90 kits (22 tests per kit))

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Sources: FDA iRES · Raw API Response

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Affected Products

510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits

510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11

Lot Numbers:

numbers

510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)

Lot Numbers:

numbers