medical MODERATE Updated 2026-03-18

Altruan GmbH recalls Clearest Strep-A Cassette Test. Test to determine the presen

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Recalled Product

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

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Hazard / Issue

Product not cleared by the FDA.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. SP-C310343-10; No UDI; Lot Code: 01242573.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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