Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Class I - DangerousWhat Should You Do?
- Check if you have this product: List Number: 09K14; Models: E series, G series
- 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
- Reason for Recall:
- Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Product Codes/Lot Numbers:
List Number: 09K14; Models: E series, G series
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0463-2015
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.