CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Osom Ultra hCG Combo Test- IVD immunoassay recalled
Princeton Biomeditech is recalling Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human, distributed in Missouri. The recall was initiated on 23 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0259-2025
- FDA event ID
- 95439
- Recalling firm
- Princeton Biomeditech, Monmouth Junction, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Aug 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +68 days |
| 6 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Distribution to MO only.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 00742860100208 Lot Number: 563L13
Where was it sold?
US Distribution to MO only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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