Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
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…
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Changchun Wancheng Bio-Electron Co., Ltd.
- Product
- Male Fertility Sperm Test for Home Use (Cassette)
- Classification
- Class II
- Units
- US Nationwide distribution in the states of TX, GA, CA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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