Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas infinity core Recalled by Roche Diagnostics Operations, Inc. Due to Alarm flags that have a "<" symbol in...
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 Operations, Inc. directly.
Affected Products
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Quantity: 26 accounts
Why Was This Recalled?
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Where Was This Sold?
This product was distributed to 19 states: AL, AK, CA, GA, HI, IL, IA, KY, MA, MI, MN, MS, MO, MT, NJ, NY, OR, SC, TN
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report