Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Class I - Dangerous 🏥 Medical Devices
Recalled: June 17, 2024 Abbott Diagnostics Technologies AS Infusion Pumps
Nationwide
What Should You Do?
- Check if you have this product: Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
- 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 Diagnostics Technologies AS
- Reason for Recall:
- Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Product Codes/Lot Numbers:
Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2736-2024
Related Recalls
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.