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U.S. Department of Health and Human Services

Class 2 Device Recall Roche COBAS 6000

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  Class 2 Device Recall Roche COBAS 6000 see related information
Date Initiated by Firm December 04, 2007
Date Posted March 04, 2008
Recall Status1 Terminated 3 on August 04, 2008
Recall Number Z-0576-2008
Recall Event ID 45984
510(K)Number K060373  
Product Classification Clinical Chemistry Analyzer - Product Code JJY
Product Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
Code Information All cce and cc system configurations with core unit software version 02-03.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
FDA Determined
Cause 2		 Software design
Action Roche Diagnostics contacted the consignee by phone on 12/4/07 and by follow-up letter dated 12/4/07. The user was instructed to discontinue use of two CRP assays on this analyzer. The letter described a workaround and that a new revision of software, due out first quarter 2008, will fix this.
Quantity in Commerce 1
Distribution USA Distribution in the state of Nebraska.
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 = JJY and Original Applicant = Roche Diagnostics
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