Device product
cobas e 801 immunoassay analyzer
Z-1249-2019
Product summary
- Event
- Event 82394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 149
- Official record key
device-enforcement:Z-1249-2019
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.