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Devices
Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Model / Serial
All units (serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724).
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin.
Product Description
Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
Language
English
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