Universal Meditech recalls DiagnosUS Ovulation Predictor Midstream REF 200-17 due to unverified safety and lack of post-market documentation. Products manufactured 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 DiagnosUS Ovulation Predictor Midstream REF 200-17 because the company is going out of business and cannot provide safety documentation. This recall affects products made after March 2021, as the company claims to hold 510(k)s but FDA has not verified their compliance.
The devices may have unknown performance characteristics because Universal Meditech cannot provide documentation showing they were manufactured safely or meet FDA requirements. The company is going out of business and cannot fulfill post-market responsibilities like safety monitoring or quality control.
Women using the DiagnosUS Ovulation Predictor Midstream REF 200-17 for fertility tracking are affected. Those who purchased the product after March 2021 are most at risk due to the company's inability to provide safety documentation.
Check for the model number 200-17 and UDI-DI code 697691538914. Products manufactured after March 2021 with lot numbers including LH-M11-2101-01 to LH-M11-2107-01 are affected.
Look for the model number 200-17 and UDI-DI code 697691538914 on the product packaging.
Universal Meditech is recalling the product because they are going out of business and cannot provide safety documentation or fulfill post-market responsibilities.
The recall record does not specify a remedy, so the official notice does not state what to do.
The recall indicates potential safety risks due to unverified manufacturing and lack of documentation, but specific hazards are not described.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0067-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0067-2024 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.
