cobas e 801 immunoassay analyzer recall
cobas e 801 immunoassay analyzer
Why was cobas e 801 immunoassay analyzer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units may experience this issue.
- Product
- cobas e 801 immunoassay analyzer
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 149
- Distribution
- 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
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)