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Princeton Biomeditech Recalls
4 recalls on record · September 12, 2012 to November 6, 2024 · Medical Devices
Recalls by year
12
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 6, 2024Medical DevicesFDA
Princeton Biomeditech Corp recalls Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum
Hazard: This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.
September 12, 2012Medical DevicesFDA
Princeton Biomeditech Corp recalls Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The Bio
Hazard: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
September 12, 2012Medical DevicesFDA
Princeton Biomeditech Corp recalls Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2
Hazard: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
September 12, 2012Medical DevicesFDA
Princeton Biomeditech Corp recalls Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Fl
Hazard: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.