Wondfo recalled 188 units of Streptococcal A At-Home Self-Test sold nationwide in the United States after regulators found the device was not FDA-cleared. The recall centers on lack of FDA clearance for safety and effectiveness. Consumers should stop using the test immediately and contact Altruan GmbH or their healthcare provider for instructions.
Product not cleared by the FDA.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Altruan GmbH or your healthcare provider for instructions. Notification method: Other
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This is an at-home test kit intended to detect group A Streptococcus bacteria. Consumers purchase it for rapid, at-home screening of strep infections.
The product has not been cleared by the FDA. That clearance normally assesses safety and effectiveness for its intended use. Without clearance, test results may be unreliable.
This recall is not described as part of a broader industry pattern in the provided information.
If the test yields inaccurate results, patients may delay treatment or undergo unnecessary antibiotic use, potentially harming health outcomes.
Model, lot, and UDI information are typically located on the device packaging or label
The recall does not specify a refund timeline; consumers should contact the manufacturer for instructions
Retain the recall notice, packaging photos, receipts, and any correspondence with the manufacturer
- Model No. 41972 - No UDI - Lot Code: 6933289812337 - Sold nationwide in the United States - Quantity: 188 units - Price: Unknown
No injuries or incidents have been reported.
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