Wondfo recalls certain Streptococcal A rapid test kits sold without proper authorization for at-home use. These kits may be distributed to non-prescription customers.
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 specific Streptococcal A rapid test kits that were sold without proper authorization. This unauthorized distribution means the kits could be used by non-prescription customers, which is not safe.
Unauthorized distribution of these test kits allows them to be sold for at-home use without proper authorization. This could lead to unsafe use by individuals who are not qualified to perform the test.
Anyone who purchased these test kits from unauthorized sellers or non-prescription channels. People using them without a prescription are at risk.
Check for the product names 'IMCO Strep A Rapid Test Strip' or 'IMCO Strep A Rapid Test' with part number STP25-IMC. Lot numbers W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007 are affected.
Look for the part number STP25-IMC and specific lot numbers listed in the recall notice.
Wondfo identified unauthorized distribution of these test kits for at-home use without proper authorization.
The recall notice does not specify a remedy, so check with the manufacturer for further instructions.
The recall indicates they were distributed without proper authorization, so they may not be safe for at-home use.
We’ve drafted a message you can send Wondfo to request your refund or repair — edit it as you like.
Subject: Recall Z-2033-2024 — Wondfo Wondfo Hello, I own a Wondfo that is covered by recall Z-2033-2024 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.
