Wondfo recalls Preview Strep A rapid test kits (part numbers PRE-STA-25 and PRE-STA-A-10) due to unauthorized distribution. These kits may be sold without proper authorization for home use.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Wondfo is recalling Preview Strep A rapid test kits with specific part numbers because they were sold without proper authorization. This unauthorized distribution means the kits could be used for home testing without being approved for that purpose.
The hazard involves unauthorized distribution of the test kits, which could lead to improper use. These kits are designed for medical use but may be sold without proper authorization for home testing, potentially causing incorrect results or safety issues.
Anyone who purchased these test kits from unauthorized sellers or non-prescription channels. People using the kits for home testing without proper authorization are at risk.
Check the part numbers: PRE-STA-25 or PRE-STA-A-10. Look for lot numbers listed in the recall notice: W03921102, W039301003, and other specific numbers provided in the recall.
Identify the part number and lot numbers listed in the recall notice to confirm if your kit is affected.
The recall is due to unauthorized distribution of the Preview Strep A test kits, which may be sold without proper authorization for home use.
Part numbers PRE-STA-25 and PRE-STA-A-10 are affected, with specific lot numbers listed in the recall notice.
The recall does not specify a stop-use action, so you do not need to stop using them immediately. However, check if your kit matches the listed part numbers and lot numbers.
We’ve drafted a message you can send Wondfo to request your refund or repair — edit it as you like.
Subject: Recall Z-2030-2024 — Wondfo Wondfo Hello, I own a Wondfo that is covered by recall Z-2030-2024 from Wondfo. 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.
