medical MODERATE Updated 2026-03-18

Altruan GmbH recalls Brand Name: Bisaf Strep A Self-Test. Test for detection of g

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Recalled Product

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

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Hazard / Issue

Product not cleared by the FDA.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. AL-42153; No UDI; Lot Code: 6952804827274.

✅ 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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