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Roche Diagnostics Operations, Inc. recalls cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of
Recalled March 30, 2016 · FDA recall Z-1233-2016 · Roche Diagnostics Operations
Hazard
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. · FDA Class II
Units
35 Units
Sold at
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Description
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.
Product
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →