Official recall record
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-05-22
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Universal Meditech Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-05-22 · US FDA — Medical Devices
OMTMO One Step Ovulation (LH) Test Strips REF 200-07 - 2023-05-22 · US FDA — Medical Devices
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE - 2023-05-22 · US FDA — Medical Devices
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
All 18 official recall notices naming Universal Meditech Inc. on this site →