The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number 00654
- 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:
- Abbott Molecular, Inc.
- Reason for Recall:
- Incorrect optical calibration
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Product Codes/Lot Numbers:
Serial Number 00654
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1518-2022
Related Recalls
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.