Recall Z-2223-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
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
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3 |
| Distribution | US distribution to WA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.