Recall Z-0259-2025— Princeton Biomeditech Corp

Name: FDA recall Z-0259-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-23

Class II · Ongoing

Class II FDA medical device recall by Princeton Biomeditech Corp, initiated 2024-08-23. It names one FDA 510(k) clearance: K944426. 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. Reason: 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..

Recalling firm: Princeton Biomeditech Corp
Classification: Class II
Status: Ongoing
Initiated: 2024-08-23
Firm location: Monmouth Junction, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K944426 — BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEPrinceton BioMeditech Corp.·cleared 1994-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.