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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-0098-2017 - Modular Pre Analytics ( EVO/Plus)
Product Usage:
The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar ...
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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-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-0100-2017 - Roche COBAS INTEGRA 800 /800 CTS Analyzer
Analyzer, Chemistry (Photometric, Discrete for Clinical use
Product Usage:
The system cobas p612 is a computer-controlled stand-alone system for aliquoti...
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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-0094-2017 - Roche/Hitachi MODULAR Analytics Combination Systems
Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer
Product Usage:
...
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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-0099-2017 - URISYS 2400 Urine Analyzer
Automated Urinalysis System
Product Usage:
The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connec...
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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-0103-2017 - VS II Aliquoter System
calculator/data processing module, for clinical use
Product Usage:
Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quan...
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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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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-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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