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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K032311
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cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnos... 2 05/03/2018 Roche Diagnostics Corporation
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagno... 2 05/03/2018 Roche Diagnostics Corporation
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnost... 2 05/03/2018 Roche Diagnostics Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnost... 2 05/03/2018 Roche Diagnostics Corporation
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6... 2 11/29/2016 Roche Diagnostics Operations, Inc.
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes An... 2 08/05/2015 Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer 2 02/02/2015 Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S An... 3 10/10/2014 Roche Diagnostics Operations, Inc.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111... 2 04/02/2014 Roche Diagnostics Operations, Inc.
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