Altruan GmbH recalled 188 units of the Clearest Strep-A Cassette Test distributed nationwide in the United States after determining the device was not cleared by the FDA. The test lacks FDA clearance. Healthcare providers and patients should stop using the test immediately and follow the manufacturer’s recall 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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The Clearest Strep-A Cassette Test is a diagnostic device used to determine the presence of group A streptococci in throat swab samples. It is marketed for clinical use by healthcare providers.
The device was not cleared by the FDA, creating regulatory and safety concerns about its use and accuracy.
This recall is not clearly described as part of a broader industry pattern in the provided data.
Consumers and clinicians face regulatory risk and potential uncertainty about test results until FDA clearance and manufacturer guidance are provided.
Recall notice from FDA enforcement and manufacturer notice for Altruan GmbH; check recall number Z-1560-2026
Timeline for refunds or replacements is not provided
Keep a copy of the recall notice, model and lot codes, and any correspondence with the manufacturer
Model No. SP-C310343-10; No UDI; Lot Code: 01242573. Sold nationwide in the United States. 188 units recalled. Price and sold-from details are not provided.
No injuries or incidents have been reported.
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