Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer

Recall date

March 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1249-2019

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

cobas e 801 immunoassay analyzer