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
Published November 6, 2024 · Recall initiated: August 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Princeton Biomeditech Corp
- Distributor
- US Distribution to MO only.
- Lot
- UDI-DI: 00742860100208 Lot Number: 563L13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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