Z-2223-2017 Class II Terminated
FDA device recall Z-2223-2017 was initiated by Roche Diagnostics Corporation on May 9, 2017 and is designated Class II. 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… The recall status is terminated (terminated February 2, 2018). Affected quantity: 3.
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