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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0104-2017 - RSD 800A Aliquoting System
calculator/data processing module, for clinical use
Product Usage:
The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled s...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0105-2017 - RSD 800 Sorting System
calculator/data processing module, for clinical use
Product Usage:
The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intend...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0106-2017 - cobas p 612 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Product Usage:
The cobas 6000 series is a fully automated, random-access, software-controlled system for ...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0107-2017 - cobas p 512 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Product Usage:
The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0108-2017 - cobas p 471 centrifuge unit
calculator/data processing module, for clinical use
Product Usage:
The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and dec...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0109-2017 - cobas p 312 Pre-Analytical System
calculator/data processing module, for clinical use
Product Usage:
The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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Z-0095-2017 - cobas e411 Immunoassay Analyzer
e411: Immunoassay Analyzer
Product Usage:
The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigera...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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