cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

Recall Insight

This FDA Devices action (record #Z-1233-2016) was formally reported on March 30, 2016, with the manufacturer initiating the action on February 23, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records indicate 35 Units units are affected.

The documented reason for this recall is: 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 dr… Distribution data in the federal record shows the product reached: US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.