Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.
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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The Bisaf Strep A Self-Test is a home or point-of-care throat swab test intended to detect group A streptococcal antigens. It is marketed for rapid results and convenience.
The hazard is regulatory rather than a device defect. Without FDA clearance, there is regulatory risk and potential questions about performance and reliability.
This recall is not described as part of a broader industry pattern in the provided data.
Consumers should stop using the device to avoid potential regulatory or performance concerns. No injuries reported yet.
Look on the device packaging for model and batch information.
Refunds or replacements timelines are not specified in the summary; follow manufacturer guidance and FDA updates.
Keep packaging, model and batch information, and recall notices for future reference.
Product: Bisaf Strep A Self-Test. Purpose: Detection of group A streptococcal antigens in throat swabs. Quantity: 188 units. Distribution: US nationwide. Manufacturer: Altruan GmbH. Model No.: AL-42153. Lot Code: 6952804827274. UDI: No UDI.
No injuries or incidents have been reported in the provided data.
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