Z-0108-2020Class II

cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR...

Name: Z-0108-2020 cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-08-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-08-28 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122 on 2019-08-28. FDA classified it as Class II and gives the reason as "Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0108-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Posted: 2019-10-09
Terminated: 2020-10-02
Recalling firm: Roche Diagnostics GmbH
Product: cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Product code: DDG Transferrin, Antigen, Antiserum, Control
Reason for recall: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
FDA root cause: Under Investigation by firm
Action: Roche issued notification to consignees by Urgent Medical Device Correction (TP-00754) sent via UPS (signature required) on 8/28/19. The UMDC will also be available on diagnostics.roche.com. The letter identifies the problem, risk to health and action to take: Be aware of new interference claims that are listed in this UMDC and that the rhEPO Therapy Monitoring Statement will be removed from the Method Sheets. The UMDC will serve as intermediate labeling until the updated method sheets are available. Complete all sections of the enclosed fax form. 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 if you have questions
Quantity in commerce: 6,494 units
Distribution: Nationwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0109-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09

Product code DDG

K003064Class IITina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323Roche Diagnostics Corp. / cleared 2001-05-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)