cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number 08445605190 08445567190 08253153190 08058580190
  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:
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Product Codes/Lot Numbers:

Catalog Number 08445605190 08445567190 08253153190 08058580190

Distribution:

Distributed in: IL, FL, GA, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0752-2021

Related Recalls