Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cobas connection module (CCM) OUTPUT UNIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cobas connection module (CCM) OUTPUT UNIT see related information
Date Initiated by Firm May 09, 2017
Create Date June 02, 2017
Recall Status1 Terminated 3 on February 02, 2018
Recall Number Z-2223-2017
Recall Event ID 77243
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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
Code Information Serial Number 204C5690 204H0157 204H0158 
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 3
Distribution US distribution to WA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-