Universal Meditech recalls PrestiBio Ketone Test Strips (model 900-1KET) due to unverified safety and lack of post-market support. All units made after March 2021 are affected.
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.
Universal Meditech is recalling PrestiBio Ketone Test Strips (model 900-1KET) because they were distributed without proper FDA approval and the company is going out of business. This means the test strips may not work safely or effectively as intended.
The test strips were distributed without FDA marketing authorization and the manufacturer is going out of business. This means they lack required safety documentation and post-market support, which could lead to inaccurate results or unsafe use.
Users of PrestiBio Ketone Test Strips (model 900-1KET) made after March 2021 are affected. People relying on these strips for ketone testing may be at risk due to unverified safety.
Check for the model number 900-1KET on the test strips. Products manufactured after March 2021 are affected. There is no unique identifier code provided.
Look for the model number 900-1KET and verify the production date is after March 2021.
Universal Meditech is recalling these test strips because they were distributed without FDA approval and the company is going out of business, meaning they cannot provide post-market support or safety documentation.
The recall indicates potential safety issues due to unverified performance and lack of post-market support, but specific risks like injury or inaccurate results are not clearly stated.
The recall record does not specify a remedy, so check the product details and contact Universal Meditech if you have questions.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0056-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0056-2024 from Universal Meditech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
