FDA Medical devices recall ·
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection… recall
- Recall number
- Z-0259-2025
- Date
- (initiated August 23, 2024)
- Company / brand
- Princeton Biomeditech Corp
4242 US Highway 1, Monmouth Junction, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,860 kits (50,220 test devices)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00742860100208 Lot Number: 563L13
Distribution
US Distribution to MO only.
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0259-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.