Reported Apr 4, 2018 · Terminated
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog…
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?
- c6000, Chemistry (Photometric, Discrete), for clinical use. -
- cobas e 601 moduleImmunoassay Analyzer
- Catalog Numbers
0474592200105036348001058606520010474592269205036348001 & 05036348692
- Lot codes and dates
- None
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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