Z-0259-2025 Class II Ongoing
FDA device recall Z-0259-2025 was initiated by Princeton Biomeditech Corp on August 23, 2024 and is designated Class II. 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.… The recall status is ongoing. Affected quantity: 1,860 kits (50,220 test devices).
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- August 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,860 kits (50,220 test devices)
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.
Distribution Pattern
US Distribution to MO only.
Code Information
UDI-DI: 00742860100208 Lot Number: 563L13