Company: Roche Diagnostics Operations, Inc. .
Date of Enforcement Report 3/30/2016
Class lI:
PRODUCT
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Recall Number Z-1233-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN on 3/23/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
33
DISTRIBUTION
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
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