cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers - 1001 through 1037, and 502
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Product Codes/Lot Numbers:
Serial Numbers - 1001 through 1037, and 502
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1928-2019
Related Recalls
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics
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.