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U.S. Department of Health and Human Services

Medical Device Recalls

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Related Medical Device Recalls
 
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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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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 ... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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 ... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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 ... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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