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

Changchun Wancheng Bio-Electron Co., Ltd.: Male Fertility Sperm Test for Home

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

Recall reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.. Recalled by Changchun Wancheng Bio-Electron Co., Ltd.. Distribution: US Nationwide distribution in the states of TX, GA, CA.. Classification (Class II — potential health risk). Affected lots/dates: Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027). Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, re

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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