DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Recall
Issued November 1, 2023 · Universal Meditech Inc.
In November 2023, Universal Meditech Inc. recalled the DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Universal Meditech Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Universal Meditech Inc.
- Category
- Health
- Recall date
- November 1, 2023
- Units affected
- Not reported
- Sold at
- U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
- Recall number
- FDA-Z-0059-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Universal Meditech Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.