Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1249-2019)

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:

cobas e 801 immunoassay analyzer

Product Classification:

Class II

Date Initiated: March 15, 2019

Date Posted: May 8, 2019

Recall Number: Z-1249-2019

Event ID: 82394

Reason for Recall:

The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.

Status: Terminated

Product Quantity: 149

Code Information:

All units may experience this issue.

Distribution Pattern:

Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI

Voluntary or Mandated:

Voluntary: Firm initiated