cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000
  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:
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
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/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001

Product Codes/Lot Numbers:

Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0461-2021

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