Z-2223-2017Class II

Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the...

Name: Z-2223-2017 Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the...
Creator: Roche Diagnostics Corporation
Published: 2017-05-09
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2017-05-09 / Terminated / root cause: design

FDA source

Roche Diagnostics Corporation began a recall of 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... on 2017-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2223-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-02
Terminated: 2018-02-02
Recalling firm: Roche Diagnostics GmbH
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: design
FDA 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 [email protected]. 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.
Product codes and lots: Serial Number 204C5690 204H0157 204H0158

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2223-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2223-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)