Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1233-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: March 30, 2016

Recall Number: Z-1233-2016

Event ID: 73292

Reason for Recall:

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.

Status: Terminated

Product Quantity: 35 Units

Code Information:

Part numbers:05083435001 and 06268854001

Distribution Pattern:

US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA

Voluntary or Mandated:

Voluntary: Firm initiated