medical Class II Updated 2019-05-08

Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer

Recalled Product

cobas e 801 immunoassay analyzer


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI
Lot/Code Info: All units may experience this issue.
View official government recall

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