The Recall Desk

FDA (Devices) recall action 62537

Princeton Biomeditech Corp recalled 3 products on 2012-09-12

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-09-12
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2012-09-12

    Princeton Biomeditech Recalls Orasure QuickFlu Rapid A+B Test Kits

    Princeton Biomeditech is recalling Orasure QuickFlu Rapid A+B Test kits due to reports of dual positive results for Flu A and Flu B.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2012-09-12

    Princeton Biomeditech Recalls Status Flu A + B Test Kits

    Princeton Biomeditech is recalling 90 kits of the Status Flu A + B Test due to reports of dual positive results.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2012-09-12

    Princeton Biomeditech Recalls Poly stat Flu A & B Test Kits

    Princeton Biomeditech Corp is recalling 103 kits of the Poly stat Flu A & B Test due to reports of dual positive results.

    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…
    Category
    Distribution
    3 states