cobas Liat Analyzer, for in vitro diagnostic use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
- 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:
- Roche Molecular Systems, Inc.
- Reason for Recall:
- Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
cobas Liat Analyzer, for in vitro diagnostic use.
Product Codes/Lot Numbers:
Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
Distribution:
Distributed in: US, TX, NC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2543-2015
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