Reported Jun 20, 2018 · Terminated
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled…
Roche Diagnostics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
- Lot codes and dates
- Serial numbers
1744-081744-091744-101758-081606-091752-051752-061630-081738-011744-071758-091759-041758-061758-071743-091743-101752-041759-0517C5-0617C5-071615-081612-1017C5-091744-051744-061743-071743-081744-031744-041759-0617C5-0517C5-0817C5-1017C6-0117C6-02
- Serial numbers
- Amount recalled
- 35
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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