Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas e 801 immunoassay analyzer Recalled by Roche Diagnostics Corporation Due to The firm has confirmed complaints regarding signal drops...
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 e 801 immunoassay analyzer
Quantity: 149
Why Was This Recalled?
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, CA, CT, FL, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, VA, WA, WI
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report