The Recall Desk

Manufacturer

Princeton Biomeditech Corp

4 recalls in our database name Princeton Biomeditech Corp as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2024-11-06

Of the 4 recalls from Princeton Biomeditech Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • HighFDA (Devices)·Z-0259-2025·2024-11-06

    Pregnancy Test Kits Recalled for False Negative Results

    Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.

    Product
    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2307-2012·2012-09-12

    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 nucle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2012·2012-09-12

    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, nasopharynge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2012·2012-09-12

    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 swab
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Princeton BioMeditech (United States)

company in Monmouth Beach, United States

Country
United States
Founded
1988

Official website

Source: Wikidata (Q64142363), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.