Z-2136-2018Class II

cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software...

Name: Z-2136-2018 cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software...
Creator: Roche Diagnostics Corporation
Published: 2018-04-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-04-03 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of... on 2018-04-03. FDA classified it as Class II and gives the reason as "The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function". 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-2136-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-03
Posted: 2018-06-10
Terminated: 2019-11-21
Recalling firm: Roche Diagnostics GmbH
Product: cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On April 3, 2018, The Firm sent an Urgent Medical Device Correction letter via UPS Ground. Consignees were notified of the possible failure. Consignees were informed that a Roche representative would contact them to install a syringe plunger guide for the affected syringes to resolve the issue. In the meantime, consignees were instructed to only measure assays that do not require prewash steps and assays that are not impacted by missing prewash step until the syringe plunger guide is installed on the affected module. If the customer identifies broken syringe plungers on their device, the notice instructed them to contact the Roche Support Network Customer Support Center at 1-800-428-2336, available 24 hours a day, 7 days a week. Customers were asked to complete a customer response form and return it to the firm.
Quantity in commerce: 35
Distribution: US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
Product codes and lots: Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)