Princeton Biomeditech Corp: Device Recall

Recall #Z-0259-2025 · 08/23/2024

Class II: Risk

Recall Details

Recall Number: Z-0259-2025
Classification: Class II
Product Type: Device
Recalling Firm: Princeton Biomeditech Corp
Status: Ongoing
Date Initiated: 08/23/2024
Location: Monmouth Junction, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,860 kits (50,220 test devices)

Reason for Recall

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.

Product Description

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

Distribution Pattern

US Distribution to MO only.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.