Roche Diagnostics Corporation: Medical Device Recall in 2017 - (Recall #: Z-2223-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 9, 2017

Date Posted: June 14, 2017

Recall Number: Z-2223-2017

Event ID: 77243

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.

Status: Terminated

Product Quantity: 3

Code Information:

Serial Number 204C5690 204H0157 204H0158

Distribution Pattern:

US distribution to WA only.

Voluntary or Mandated:

Voluntary: Firm initiated