Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas pro integrated solutions -cobas c 503 Recalled by Roche Diagnostics Operations, Inc. Due to During the subsequent pipetting (1st or 2nd measurement),...
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 pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Quantity: 152 kits and 7 units
Why Was This Recalled?
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Where Was This Sold?
This product was distributed to 4 states: FL, GA, IL, WV
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