Reported Nov 6, 2024 · Ongoing
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum…
Princeton Biomeditech Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Princeton Biomeditech Corp · 4242 US Highway 1 · Monmouth Junction, NJ · 08852-1905
Is this the product you have?
- 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 Number1004
- Lot codes and dates
- UDI-DI00742860100208
- Lot Number563L13
- Amount recalled
- 1,860 kits (50,220 test devices)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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