Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Class I - DangerousWhat Should You Do?
- Check if you have this product: serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vital Scientific N.V.
- Reason for Recall:
- The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Product Codes/Lot Numbers:
serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0157-2020
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