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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-0101-2017 - cobas p 701 Post-Analytical Unit
calculator/data processing module, for clinical use
Product Usage:
The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitati...
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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-0102-2017 - cobas p 501 Post-Analytical Unit
calculator/data processing module, for clinical use
Product Usage:
The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, includi...
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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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Z-0097-2017 - cobas 8000 Modular Analyzer Series
c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer
Product Usage:
The VS II system is a stand-alone, computer-controll...
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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-0110-2017 - cobas 6800/8800 system
Hepatitis Viral B DNA Detection
Product Usage:
The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded ...
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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-0096-2017 - cobas 6000 Series system
c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer
Product Usage:
The cobas p501/p701 instrument stores primary and secondary ...
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2
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10/25/2016
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Roche Diagnostics Operations, Inc.
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