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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi Modular P800 Module GMMI clinical chemistry analyzer

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  Class 2 Device Recall Roche/Hitachi Modular P800 Module GMMI clinical chemistry analyzer see related information
Date Initiated by Firm March 21, 2008
Date Posted August 13, 2008
Recall Status1 Terminated 3 on November 18, 2009
Recall Number Z-0867-2008
Recall Event ID 47371
510(K)Number K953239  
Product Classification Chemistry analyzer - Product Code JJE
Product Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001.

Intended for qualitative and quantitative in vitro determinations using a wide variety of tests.

Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
Code Information All units with software version 08-02.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Possible mismatch between patient and result.
FDA Determined
Cause 2		 Process change control
Action Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
Quantity in Commerce 11 of all models
Distribution Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
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