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
This recall has been terminated (originally issued May 9, 2017).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- May 9, 2017
- Terminated
- February 2, 2018
- Recall Number
- Z-2223-2017
- Quantity
- 3
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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
US distribution to WA only.
Lot / Code Info
Serial Number 204C5690 204H0157 204H0158
Root Cause
Device Design
Action Taken
Roche sent an Urgent Medical Device Correction letter dated May 9, 2017, to all affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were asked to complete the attached form and fax it to 877-906-8982 or email to Indianapolis.cd_tsc@roche.com. Consignees with questions were instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336.