DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Enforcement
- Recall Number
- Z-0065-2024
- Event ID
- 92659
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Universal Meditech Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- November 1, 2023
- Initiation Date
- May 22, 2023
- Classification Date
- October 23, 2023
- Address
- 850 I St, N/A, Reedley, CA, 93654-2819, United States
Description
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
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.
Model Number: 100-27 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG-M5-2106-03
U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
1,000 cassettes