Z-1249-2019Class II

cobas e 801 immunoassay analyzer

Name: Z-1249-2019 cobas e 801 immunoassay analyzer
Creator: Roche Diagnostics Corporation
Published: 2019-03-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-03-15 / Terminated / root cause: design

FDA source

Roche Diagnostics Corporation began a recall of cobas e 801 immunoassay analyzer on 2019-03-15. FDA classified it as Class II and gives the reason as "The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment". 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-1249-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-15
Posted: 2019-05-02
Terminated: 2020-04-23
Recalling firm: Roche Diagnostics GmbH
Product: cobas e 801 immunoassay analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
Root cause tag: design
FDA root cause: Device Design
Action: On March 15, 2019, the firm notified affected customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the potential problem of signal drops when the standby bottle flowpath is covered with a biofilm. Customers were asked to do the following: " Follow the Workaround section to determine if your cobas e 801 module is potentially affected and perform the steps if applicable. " If your cobas e 801 module is potentially affected based on the information in the Workaround section of this UMDC, contact the Roche Support Network Customer Support Center at 1-800-428-2336 to schedule the ProCell II M flowpath decontamination procedure. The ProCell II M flowpath decontamination procedure should be performed every 4 weeks until your cobas e 801 module is switched to the improved ProCell II M formulation. " Identify and retest potentially affected patient samples using the Retrospectively Identify and Correct Potentially Affected Patient Sample Results section of this UMDC. " Complete the attached fax form and fax it to 1-833-254-2597 or email it to [email protected].
Quantity in commerce: 149
Distribution: Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI
Product codes and lots: All units may experience this issue.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1249-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code JJE

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)