Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 6, 2024
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
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 fa…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Princeton Biomeditech Corp recalled Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorion… - a moderate-severity action.
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorion… was recalled by Princeton Biomeditech Corp in November 6, 2024. Reason: This recall was initiated due to customer complaints of false negative of hCG test results when running patie…. Check the official notice for the remedy. Verify recall #Z-0259-2025 with the FDA Devices before acting.
The recall
Princeton Biomeditech Corp issued this moderate-severity FDA Devices recall-This recall was initiated due to customer complaints of false negative of hCG test results when running patie….
- Moderate
- severity level
- Class II
- classification
- November 6, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0259-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0259-2025) was formally reported on November 6, 2024, with the manufacturer initiating the action on August 23, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Princeton Biomeditech Corp is listed as the recalling firm, operating out of Monmouth Junction, NJ. Federal records list the affected scope as 1,860 kits (50,220 test devices).
The documented reason for this recall is: 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 report… Distribution data in the federal record shows the product reached: US Distribution to MO only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,860 kits (50,220 test devices)
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0259-2025 |
| Date reported | November 6, 2024 |
| Date initiated | August 23, 2024 |
| Recalling firm | Princeton Biomeditech Corp |
| Firm location | Monmouth Junction, NJ |
| Affected scope | 1,860 kits (50,220 test devices) |
| Distribution | US Distribution to MO only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0259-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Princeton Biomeditech Corp. Units affected: 1,860 kits (50,220 test devices).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0259-2025.
Where was the recalled product distributed? ▼
Distribution: US Distribution to MO only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0259-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 6, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.