cobas e 801 immunoassay analyzer recall
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro…
Why was cobas e 801 immunoassay analyzer recalled?
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
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?
Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02
- Product
- cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 35
- Distribution
- US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)