Cl II Roche MODULAR ANALYTICS EVO

Company: Roche Diagnostics Operations, Inc.
Date of Enforcement Report:6/25/2014
Class lI:

PRODUCT

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator’s Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Recall Number Z-1790-2014

REASON
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms..

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN on 5/29/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
462

DISTRIBUTION
Nationwide

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