Princeton Biomeditech Corp recalls Osom Ultra hCG Combo Test due to false negative results in pregnancy tests. Affected lots may give incorrect negative results for hCG-positive samples.
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.
Princeton Biomeditech Corp is recalling Osom Ultra hCG Combo Test kits after customer reports of false negative results when testing urine samples. This could lead to incorrect pregnancy conclusions if the test is used on hCG-positive samples.
The test may produce false negative results when detecting hCG in urine samples. This means a pregnant person could get a negative result even though they are pregnant, potentially delaying necessary care.
Pregnancy test users who purchased the Osom Ultra hCG Combo Test kit with lot number 563L13 are affected. Women who rely on this test for early pregnancy confirmation may be at risk of false negatives.
Check for the model number 1004 or lot number 563L13 on the test kit. The product was sold as an IVD immunoassay for hCG detection in serum or urine.
Look for the model number 1004 or lot number 563L13 on the test kit to confirm if it is affected.
The recall was initiated due to customer complaints of false negative results when testing urine samples. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative results from two patient urine samples as confirmed by quantitative hCG and ultrasound.
Check for the model number 1004 or lot number 563L13 on the test kit. The product was sold as an IVD immunoassay for hCG detection in serum or urine.
The recall record does not specify a remedy, so the official notice does not provide instructions for action.
We’ve drafted a message you can send Osom to request your refund or repair — edit it as you like.
Subject: Recall Z-0259-2025 — Osom Osom Hello, I own a Osom that is covered by recall Z-0259-2025 from Osom. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
