device · product 1 of 1
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
- Recall number
- Z-0259-2025
- Initiated
- August 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Princeton Biomeditech Corp
- Quantity
- 1,860 kits (50,220 test devices)
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Sourced
Process change control
Inspect official wording and provenance
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.
Code information
UDI-DI: 00742860100208 Lot Number: 563L13
Distribution pattern
US Distribution to MO only.