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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJY
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