Devices

Device Recall Elecsys 2010 Analyzer Software version 0607

Model / Serial
Elecsys 2010 Analyzer Rack: 11804014001 Elecsys 2010 Analyzer Disk: 11568248001 Software version 06-07: 06526080001, 06569668001
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA including NY, GA, DE, SD, WI, ME, OR, IA, AND CA and the countries of Austria, Cyprus, Czech Republic, Estonia, France, Germany,Greece, Hungary, Iceland, Italy, Latvia, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland
Product Description
Elecsys 2010 Analyzer Software version 06-07 || The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall Elecsys 2010 Analyzer Software version 0607

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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