Z-2478-2019Class II

cobas c513 Analyzer

Name: Z-2478-2019 cobas c513 Analyzer
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-07-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-07-18 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas c513 Analyzer on 2019-07-18. FDA classified it as Class II and gives the reason as "Quality issue with high pressure solenoid valves". 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-2478-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-18
Posted: 2019-09-05
Terminated: 2020-06-15
Recalling firm: Roche Diagnostics GmbH
Product: cobas c513 Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Quality issue with high pressure solenoid valves
Root cause tag: design
FDA root cause: Device Design
Action: 1. For the cobas 8000 ISE, cobas c 701, and cobas c 702 modules and the cobas c 513 analyzer, stop using these units immediately. Your FES will be in contact with you to replace these affected high pressure solenoid valves immediately. 2. In the event that the high pressure solenoid valves cannot be replaced immediately, for the cobas e 601 module, follow the wash station checks outlined in this Urgent Medical Device Correction (UMDC). Perform these checks once per shift. If these checks show favorable outcomes and quality control results are within range, patient results may be reported. If these checks produce unfavorable outcomes, stop using your cobas e 601 module and call the Roche Support Network Customer Support Center at 1-800-428-2336. 3. Complete the attached fax form and fax or email it according to the instructions on the form. 4. File this Urgent Medical Device Correction (UMDC) for future reference Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in commerce: 2 units
Distribution: State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Product codes and lots: Serial # :1731-08, 1722-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2478-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2476-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2477-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2478-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05

Product code JJE

K160571Class IIcobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (Rdo) / cleared 2016-12-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)