Universal Meditech recalls DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 due to unverified safety and regulatory compliance. 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 DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 because the company is going out of business and cannot meet post-market safety requirements. This recall affects all units manufactured after March 2021 due to unverified regulatory compliance.
The recall states that Universal Meditech is going out of business and cannot fulfill post-market responsibilities. The company claims to hold 510(k)s but FDA has not verified their documentation for safety and effectiveness, which could lead to unknown risks.
Pregnancy test users who purchased DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 after March 2021 are affected. Those who used the test without verifying the manufacturer's compliance status are at higher risk.
Check for model number 100-13 on the cassette. Products manufactured after March 2021 are affected, including specific lot numbers like hCG-M5-2103-01.
Identify the model number and production date to confirm if the product is affected.
Universal Meditech is going out of business and cannot meet post-market safety responsibilities, so the FDA has initiated a recall due to unverified regulatory compliance.
The recall indicates potential safety risks because Universal Meditech cannot provide documentation confirming the product's safety and effectiveness, but specific hazards are not described.
Check the model number and production date. If it's a product made after March 2021, contact Universal Meditech for guidance.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0064-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0064-2024 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.
