FDA-Device2017-06-14Class II
Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
Roche Diagnostics Corporation
Hazard
a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a potential risk to involved operators and can also lead to potential cross contamination of samples in the affected racks.
Sold states
US distribution to WA only.
Affected count
3
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2223-2017Don't want to check this manually?
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