cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling the cobas p 512 pre-analytical system due to a defect in the lifting gripper mechanism. When the gripper's READY signal falsely triggers or is incorrectly detected, sample tubes are not properly replaced in the Rack Tube Transport after the decapping process. This can result in open sample tubes being dropped inside the machine and spilling their contents.
The recall affects 35 units of the cobas p 512 system distributed across the United States, including Puerto Rico and the states of Texas, Ohio, Tennessee, Arizona, Washington, Michigan, and Georgia. The affected equipment has part numbers 05083435001 and 06268854001. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA Quantity: 35 Units Lot/code info: Part numbers:05083435001 and 06268854001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.