Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Altruan
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 Diagnostic Cassette Test
- Model numbers
- SP-C310343-10, No UDI, Lot Code 01242573
- Sold at
- Multiple Retailers
- 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 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.
Why This Is Dangerous
The device was not cleared by the FDA, creating regulatory and safety concerns about its use and accuracy.
Industry Context
This recall is not clearly described as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers and clinicians face regulatory risk and potential uncertainty about test results until FDA clearance and manufacturer guidance are provided.
Practical Guidance
How to identify if yours is affected
- Verify model number SP-C310343-10
- Check Lot Code 01242573
- Confirm no FDA clearance for the device
- Note distribution as US nationwide
- Refer to recall Z-1560-2026 on FDA enforcement page
Where to find product info
Recall notice from FDA enforcement and manufacturer notice for Altruan GmbH; check recall number Z-1560-2026
What timeline to expect
Timeline for refunds or replacements is not provided
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- File a complaint with the FDA if the manufacturer is unresponsive
- Consider seeking legal advice for unaddressed safety concerns
How to prevent similar issues
- Always verify FDA clearance before purchasing diagnostic tests
- Prefer FDA-cleared tests from reputable manufacturers
- Check for FDA recall notices before use
Documentation advice
Keep a copy of the recall notice, model and lot codes, and any correspondence with the manufacturer
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed nationwide in the US
- FDA clearance not obtained
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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