🔍 RecallPedia

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Class I - Dangerous
🏥 Medical Devices Recalled: July 18, 2019 Roche Diagnostics Operations Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Serial # : 31A1-01
  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:
Roche Diagnostics Operations, Inc.
Reason for Recall:
Quality issue with high pressure solenoid valves may cause inaccurate results.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Product Codes/Lot Numbers:

Serial # : 31A1-01

Distribution:

Distributed in: NY, MT, HI, IN, MD, TX, OH, KS, KY, CA, FL, OR, LA, MO, AK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2476-2019

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