🔍 RecallPedia

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Class I - Dangerous
🏥 Medical Devices Recalled: June 24, 2021 Roche Diagnostics Operations Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
  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:
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
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 central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Product Codes/Lot Numbers:

UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2444-2021

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