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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67762
Product Type Devices
Status Ongoing
Recalling Firm Roche Diagnostics Operations, Inc.
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA Nationwide Distribution including San Juan PR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. not applicable Class II The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobasĀ® 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures that manually filled cassettes are at the proper level. 76 units Z-1449-2014
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