Recall Z-0044-2020
Roche Diagnostics Operations, Inc. · initiated August 13, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274
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
FDA-determined cause: Process change control
Action taken
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
Details
- Recall number
- Z-0044-2020
- Initiated
- August 13, 2019
- Terminated
- June 30, 2022
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Quantity
- 935 units
- Distribution
- Nationwide
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN