Universal Meditech Inc.: Medical Device Recall in 2023 - (Recall #: Z-0063-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Product Classification:

Class II

Date Initiated: May 22, 2023

Date Posted: November 1, 2023

Recall Number: Z-0063-2024

Event ID: 92659

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.

Status: Ongoing

Product Quantity: 5,025 tests

Code Information:

Model Number: 100-12 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG-S-2101-01 hCG-S-2111-01-S hCG-S-2112-01

Distribution Pattern:

U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Voluntary or Mandated:

Voluntary: Firm initiated