PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS — Class II medical device recall Z-0051-2024
Ongoing recall by Universal Meditech Inc., reported 2023-11-01, distributed in CA, FL, IL, LA, NJ, NY, TX, WY. Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS
| Recall number | Z-0051-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Universal Meditech Inc., Reedley, CA, United States |
| Recall initiated | 2023-05-22 |
| Classified | 2023-10-23 |
| Reported by FDA | 2023-11-01 |
| Distributed | CA, FL, IL, LA, NJ, NY, TX, WY |
| Countries outside the US | TW |
| Model numbers | 910-10 |
Product
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.