🔍 RecallPedia

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001

Class I - Dangerous
🏥 Medical Devices Recalled: December 17, 2020 Roche Diagnostics Operations Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All versions from cobas infinity version 3.00.00 onwards
  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:
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001

Product Codes/Lot Numbers:

All versions from cobas infinity version 3.00.00 onwards

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0883-2021

Related Recalls