Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobas 8000 Modular Series system Recalled by Roche Diagnostics Corporation Due to A software failure may incorrectly set the system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Quantity: 399
Why Was This Recalled?
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Where Was This Sold?
This product was distributed to 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report