FDAFDA · Food and drugs·Recall number Z-1249-2019
cobas e 801 immunoassay analyzer
Published May 8, 2019 · Recall initiated: March 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Corporation
- Distributor
- 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
- Lot
- All units may experience this issue.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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