Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The COBAS INTEGRA 400/400 plus system (software version 3.4) is Recalled by Roche Molecular Systems, Inc. Due to Roche Molecular Systems, Inc. has become aware of...
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 Molecular Systems, Inc. directly.
Affected Products
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Quantity: 855 units.
Why Was This Recalled?
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report