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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi Modular E Module

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 Class 2 Recall
Roche/Hitachi Modular E Module
see related information
Date Posted October 22, 2008
Recall Status1 Terminated on October 22, 2009
Recall Number Z-0165-2009
Recall Event ID 48711
Premarket Notification
510(K) Number
K961481 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
Code Information All units with software version 08-02.
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis, Indiana 46256-1025
Manufacturer Reason
for Recall
A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
Distribution Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
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