Z-1270-2018Class II

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers...

Name: Z-1270-2018 cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers...
Creator: Roche Diagnostics Corporation
Published: 2017-12-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2017-12-18 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corporation began a recall of cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system)... on 2017-12-18. FDA classified it as Class II and gives the reason as "Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1270-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Posted: 2018-03-28
Terminated: 2019-04-09
Recalling firm: Roche Diagnostics GmbH
Product: cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Roche Diagnostics Corporation issued Urgent Medical Device Correction (UMDC) notices and Fax Forms to their customers dated 12/18/2017 via UPS Ground (receipt required). Customers are encouraged to do the following Mandatory Steps to improve the vertical alignment and handling of 13 mm sample tubes and false bottom tubes: FOR cobas e 411 & cobas e 601 analyzers and MODULAR ANALYTICS E 170 module: 1) Always use Roche rack cup adapters with 13 mm tubes 2) Ensure sample tubes are straight FOR cobas e 411 disk system: 1) Always use 13 mm Sample Disk Tube Adapters (SDTAs) with 13 mm sample tubes. 2) Ensure sample tubes are straight. 3) Ensure 13 mm SDTAs are not exposed to direct sunlight. 4) If a larger diameter tube is left inserted in a 13 mm SDTA for more than 3 days, the adapter may become distorted. Do not insert smaller diameter tubes into distorted adapter as they may not align correctly. **All customers are encouraged to DISCARD Analyzer Bulletin 10-009U3. Follow the care and handling instructions for using adapters as outlined in this Urgent Medical Device Correction (UMDC) and complete & return the UMDC fax form via fax to 1-877-271-1472
Distribution: US Nationwide
Product codes and lots: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1270-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1269-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1270-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

Product code JJE

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)