Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes Recalled by Roche Diagnostics Operations, Inc. Due to Due to a false triggering or detection 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 Diagnostics Operations, Inc. directly.
Affected Products
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Quantity: 35 Units
Why Was This Recalled?
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
Where Was This Sold?
This product was distributed to 7 states: AZ, GA, MI, OH, TN, TX, WA
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