Recall archive / FDA device enforcement
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 — FDA record Z-0049-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
- Reason
- Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
- Classification
- Class II
- Recalling firm
- Universal Meditech Inc.
- Quantity
- 45,420 tests
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0049-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 100-17 UDI-DI Code: Lot Numbers: hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM-2209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 1, 2023
- Recall initiation date
- May 22, 2023
- Center classification date
- Oct 23, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.