Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers 5899, 5902, and 5986.
- 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:
- Leica Biosystems Imaging, Inc.
- Reason for Recall:
- The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Product Codes/Lot Numbers:
Serial numbers 5899, 5902, and 5986.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0046-2020
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