Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Vital Scientific N.V.
Reason for Recall:
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Product Codes/Lot Numbers:

serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0158-2020

Related Recalls