FDA-Device2016-03-30Class II
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Roche Diagnostics Operations, Inc.
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.
Sold states
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Affected count
35 Units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2016Don't want to check this manually?
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