Medical Device Recalls

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510(K) Number: K100853

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 mod...	2	12/30/2020	Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701...	2	09/05/2019	Roche Diagnostics Operations, Inc.
cobas e 801 immunoassay analyzer	2	05/02/2019	Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, soft...	2	06/10/2018	Roche Diagnostics Corporation
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module	2	03/06/2018	Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001	2	02/21/2018	Roche Diagnostics Corporation
Brand Name: ® cobas c 6000 MODULAR Series System e 601 ® cobas c 8000 MODULAR Series System - e ...	2	01/16/2018	Roche Diagnostics Corporation
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas ...	2	05/09/2017	Roche Diagnostics Corporation
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modula...	2	10/25/2016	Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analy...	2	04/10/2014	Roche Diagnostics Operations, Inc.