How do I get a refund or replacement for this recall?

Stop using the recalled product immediately. Follow the manufacturer's instructions on the official recall notice for returning or disposing of the product. Depending on the recall, you may receive a full refund, a replacement product, or a free repair. Visit the official source link on this page for claim instructions.

How do I know if my product is affected by this recall?

Check the product name, model number, lot number, or purchase date against the official recall notice. The official source link on this page contains the full list of affected units. If in doubt, stop using the product and contact the manufacturer directly.

Product Recalls & Refunds Online / National

Universal Meditech Inc.: DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Category Product Recalls & Refunds

Location National

Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.

Source Official Source ↗

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