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
FDA Recall Z-0044-2020 · Posted None
Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJLW
Date Initiated2019-08-13
Date Terminated2022-06-30
Product Quantity935 units
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
Firm 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
Root Cause
Process change control
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.