Reedley, CA, United States
Universal Meditech Inc. recalls
2 recalls recorded since 2018, most recently on 22 May 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 22 May 2023
- 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.
- Distribution
- U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0059-2024, Z-0055-2024, Z-0057-2024, Z-0066-2024, Z-0056-2024, Z-0061-2024, Z-0048-2024, Z-0068-2024, Z-0042-2024, Z-0044-2024, Z-0052-2024, Z-0060-2024 and 15 more
- DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
- PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
- PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
- DiagnosUS Pregnancy Test Midstream REF 100-17
- PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
- Lem Fertility hCG Pregnancy Urine Test REF 100-12
- DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
- OMTMO One Step Ovulation (LH) Test Strips REF 200-07
- and 19 more product lines
Ongoing Class I Medical devices
- Recall started
- 28 November 2022
- Reason
- Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
- Distribution
- U.S. Nationwide distribution in the states of CA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0929-2023
- Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.