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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 17 Results
Related Medical Device Recalls
 
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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: ... 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.
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-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 ... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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-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-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... 2 10/25/2016 Roche Diagnostics Operations, Inc.
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