Z-0044-2020Class II

AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer...

Name: Z-0044-2020 AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-08-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-08-13 / Terminated / root cause: packaging

FDA source

Roche Diagnostics Operations, Inc. began a recall of AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes... on 2019-08-13. FDA classified it as Class II and gives the reason as "AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0044-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-13
Posted: 2019-10-04
Terminated: 2022-06-30
Recalling firm: Roche Diagnostics GmbH
Product: AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
Root cause tag: packaging
FDA root cause: Process change control
Action: Roche Diagnostics issued Urgent Medical Notification letter to Distributor (TP-00744) and end users( TP-00741) on 8/13/19. Letter identifies problem, health risk and Actions required per the UMDC: " Check to see if you have any of the affected lot number(s) of AssayTips/AssayCup Trays on your cobas e 801 module or in your laboratory stock. (See pictures for lot number locations on packaging.). " Stop using the affected lot number(s) of AssayTips/AssayCup Trays immediately. " Discard the affected lot number(s) of AssayTips/AssayCup Trays according to your local waste management guidelines. To receive replacement product, fill out the attached fax form and fax or email it according to the instructions on the 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
Quantity in commerce: 935 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0044-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0044-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code JLW

K162606Class IIElecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics / cleared 2017-01-23

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)