FDA Device Recall Z-0044-2020: Roche Diagnostics Operations, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2020.

Recall Res Number

Z-0044-2020

Recalling Firm / Manufacturer

Roche Diagnostics Operations, Inc.

FEI Number

1823260

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-08-13

Date Posted

N/A

Date Terminated

2022-06-30

Product Code

JLW

Event Number

83646

Product Quantity

935 units

Product Description 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

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

Action Details 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

Distribution Pattern Nationwide

Code Information / Serial Numbers Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274

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Medical Device Recall: Z-0044-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer