Z-2223-2017 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
May 9, 2017
Termination Date
February 2, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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

Reason for Recall

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.

Distribution Pattern

US distribution to WA only.

Code Information

Serial Number 204C5690 204H0157 204H0158