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Device Recall cobas p 512 preanalytical system
Model / Serial
Part numbers:05083435001 and 06268854001
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Product Description
cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall cobas p 512 preanalytical system
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Manufacturer
Roche Diagnostics Operations, Inc.
Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Language
English
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