Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Altruan
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Altruan
- Product type
- Strep A Self-Test
- Model numbers
- AL-42153
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product not cleared by the FDA.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
The hazard is regulatory rather than a device defect. Without FDA clearance, there is regulatory risk and potential questions about performance and reliability.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers should stop using the device to avoid potential regulatory or performance concerns. No injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Check Model No. AL-42153
- Check Lot Code 6952804827274
- No UDI listed
Where to find product info
Look on the device packaging for model and batch information.
What timeline to expect
Refunds or replacements timelines are not specified in the summary; follow manufacturer guidance and FDA updates.
If the manufacturer is unresponsive
- Contact healthcare provider for guidance
- Report to FDA if you suspect issues
How to prevent similar issues
- Verify FDA clearance before purchasing medical tests
- Purchase from reputable retailers
- Check for updated recall notices
Documentation advice
Keep packaging, model and batch information, and recall notices for future reference.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- FDA clearance not obtained
- Model No. AL-42153
- US nationwide distribution
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