Reported Nov 1, 2023 · Ongoing
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Universal Meditech Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Universal Meditech Inc. · 850 I St · Reedley, CA · 93654-2819
Is this the product you have?
- PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
- Lot codes and dates
- Model Number900-1KET
- UDI-DI CodeNone
- Lot NumbersAll products manufactured after March 2021
- Amount recalled
- Unknown
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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