Z-2981-2020Class II

Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

Name: Z-2981-2020 Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-08-20
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-08-20 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 on 2020-08-20. FDA classified it as Class II and gives the reason as "Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2981-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-20
Posted: 2020-09-17
Terminated: 2021-10-22
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Correction notification letters dated 8/20/20 were distributed to customers. Actions Required " Be aware of the new RF interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheet (V3), anticipated in September 2020, is available. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Customers do not need to perform an additional RF test unless otherwise determined in consultation with the physician or pathologist at your facility. " Complete the attached fax back form (TP-01048) and fax or email it according to the instructions on the form. " File this UMDC for future reference. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. The Elecsys Anti-TPO method sheet is being updated with the new claim for Rheumatoid Factor (RF) interference. Until the updated method sheet (V3) is available, this Urgent Medical Device Correction serves as your labeling. When these method sheets are updated, they will be available on the diagnostics.roche.com website and on the cobas e-library. 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: 11,870 reagent kits
Distribution: US Nationwide
Product codes and lots: All current and upcoming lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2981-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2981-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-17

Product code JZO

K051890Class IIRoche Diagnostics Cobas Elecsys Anti-TpoRoche Diagnostics Corp. / cleared 2005-08-04

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)