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	FEI # 1823260 Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701...	2	09/05/2019	FEI # 1823260 Roche Diagnostics Operations, Inc.
cobas e 801 immunoassay analyzer	2	05/02/2019	FEI # 1823260 Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, soft...	2	06/10/2018	FEI # 1823260 Roche Diagnostics Corporation
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module	2	03/06/2018	FEI # 1823260 Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001	2	02/21/2018	FEI # 1823260 Roche Diagnostics Corporation
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modula...	2	10/25/2016	FEI # 1823260 Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analy...	2	04/10/2014	FEI # 1823260 Roche Diagnostics Operations, Inc.
Cobas® 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602...	2	05/23/2013	FEI # 1823260 Roche Diagnostics Operations, Inc.