Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
Wondfo USA is recalling 102,500 units of IMCO Strep A Rapid Test Kits due to unauthorized distribution for at-home, over-the-counter, and direct-to-consumer use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for unauthorized distribution through channels not approved for use. The distribution of the test kits outside approved scope represents a risk-of-harm, though no illnesses or injuries have been reported.
Plain-English summary
Wondfo USA Co Ltd is recalling 102,500 units of IMCO Strep A Rapid Test Kits (Part Number STP25-IMC) distributed nationwide in the United States.
The recall is due to unauthorized distribution. The test kits were sold and distributed for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales, which exceeds the authorized distribution scope for this medical device.
Consumers who obtained these test kits through unauthorized channels are affected. Consumers should stop using affected test kits from the listed lot numbers and consult their healthcare provider for proper Streptococcal A testing.
Affected lot numbers include: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, and W03921007. For additional information, contact the FDA or Wondfo USA.
The recalled product
- Product
- Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
- Manufacturer
- Wondfo USA Co Ltd
- Hazard
- unauthorized-distribution
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 (7)
- Lot Numbers: W039301002
- W039306002
- W039312001
- W03920403
- W03920708
- W03921003
- W03921007
Distribution
Distributed nationwide across the United States.
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