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 syringe plunger on the device may be...
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, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Quantity: 35
Why Was This Recalled?
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Where Was This Sold?
This product was distributed to 13 states: CA, CT, IN, IA, KY, ME, MI, NY, NC, OH, SC, TX, VA
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