Z-1449-2014Class II

Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer...

Name: Z-1449-2014 Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer...
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-03-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-03-13 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative... on 2014-03-13. FDA classified it as Class II and gives the reason as "The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1449-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-13
Posted: 2014-04-10
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: March 17, 2014 all consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). The notice identified the issue, root cause, affected assays with clinical significance. Consignees were instructed to follow the steps listed in the Urgent Medical Device Correction to correctly activate the ICVC and verify the correction. If your system is not connected to the Internet through the cobas link, and you do not have the option to run the affected reagents on an alternate system (i.e., cobas c 311 or cobas c 501 analyzer), please contact the Roche Support Network Customer Support Center at 1-800-428-2336 to have an update scheduled via a Roche Field Representative. If your system is connected to the Internet through the cobas link, follow the steps below: " Remove all reagent cobas c packs on board your cobas c 502 module for the assays listed on pages 1-2. " Dispose of these reagent cobas c packs according to your local waste management ordinances. " Load new cobas c packs for the affected assays, and visually verify the ICVC is performed. " Complete the attached fax form (5326-00-0314) and fax it to 1-888-276-6166. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " File this Urgent Medical Device Correction (UMDC) for future reference.
Quantity in commerce: 76 units
Distribution: USA Nationwide Distribution including San Juan PR
Product codes and lots: not applicable

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1449-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1449-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10

Product code JJE

K100853Class IICobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. / cleared 2010-09-09

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)