Pregnancy Test Kits Recalled for False Negative Results
Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall with no reported hospitalizations or injuries. The defect is documented (false negatives confirmed in testing) and poses risk of harm, but no illness or injury has been reported, meeting the rubric criterion for High severity.
Plain-English summary
Princeton Biomeditech Corp is recalling Osom Ultra hCG Combo Test kits (Model/Catalog Number 1004, Lot 563L13) distributed in Missouri. The recall affects 1,860 kits containing 50,220 test devices.
The recall was initiated due to false negative test results reported by customers. One healthcare user reported that the recalled lot produced false negative hCG results from two urine samples that were confirmed positive by quantitative hCG testing and ultrasound. During further investigation, six additional devices were found to produce false negative results when testing urine samples with confirmed hCG presence.
Osom Ultra hCG Combo Test is an immunoassay designed to qualitatively detect human chorionic gonadotropin (hCG) in serum or urine for early pregnancy confirmation. False negative results mean the test failed to detect hCG when it was actually present.
If you have purchased this product lot, do not use it for hCG testing. Contact your healthcare provider for alternative pregnancy confirmation methods.
The recalled product
- Product
- 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
- Manufacturer
- Princeton Biomeditech Corp
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00742860100208 Lot Number: 563L13
Distribution
Distributed in 1 state:
- MO
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