cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers - 1001 through 1044
  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 Corporation
Reason for Recall:
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from 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 p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Product Codes/Lot Numbers:

Serial Numbers - 1001 through 1044

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1927-2019

Related Recalls

Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

Feb 4, 2019 Other Medical Devices View Details →