Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0044-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 13, 2019

Date Posted: October 16, 2019

Recall Number: Z-0044-2020

Event ID: 83646

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

Status: Terminated

Product Quantity: 935 units

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated