Strep A Rapid Test Kits Recalled for Unauthorized Distribution
Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The issue is unauthorized distribution through non-professional channels; no specific product defect or safety hazard is described in the source.
Plain-English summary
Wondfo USA has identified that Preview Strep A rapid test kits were distributed through unauthorized channels including at-home use, non-prescription use, over-the-counter use, and direct-to-consumer customers. Approximately 1.2 million units were affected, with Part Numbers PRE-STA-25 and PRE-STA-A-10, distributed nationwide across multiple lot numbers.
The device is intended for distribution through professional channels only and should not be sold for at-home or consumer use. This recall addresses kits that reached consumers outside the authorized distribution pathway.
Consumers who have obtained this test kit through unauthorized channels should discontinue use and consult a healthcare professional for appropriate Strep A testing performed in a clinical setting. Healthcare providers and consumers with questions should contact Wondfo USA or the FDA.
The recalled product
- Product
- Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
- Manufacturer
- Wondfo USA Co Ltd
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) PRE-STA-25
- UDI/DI **
- Lot Numbers: W03921102
- W039301003
- W039301005
- W039301004
- W039309003
- W039309007
- W03910902
- W03911002
- W03910911
- W03921005
- W03921102
- W03921008
- W039212001
- W039212006
- W03920804
- b) PRE-STA-10
- Lot Numbers: W03920902
- W03921103
Distribution
Distributed nationwide across the United States.
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