🔍 RecallPedia

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Class I - Dangerous
🏥 Medical Devices Recalled: January 7, 2020 Roche Diagnostics Operations Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All cobas infinity laboratory solution software versions are affected.
  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:
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Product Codes/Lot Numbers:

All cobas infinity laboratory solution software versions are affected.

Distribution:

Distributed in: AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1158-2020

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