Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL
  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:
Siemens Healthcare Diagnostics, Inc.
Reason for Recall:
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Product Codes/Lot Numbers:

Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL

Distribution:

Distributed in: DC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2405-2020

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