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U.S. Department of Health and Human Services

Class 1 Device Recall COBAS

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  Class 1 Device Recall COBAS see related information
Date Initiated by Firm May 24, 2004
Date Posted July 27, 2004
Recall Status1 Terminated 3 on March 08, 2006
Recall Number Z-1119-04
Recall Event ID 29358
510(K)Number K012966  
Product Classification Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
Product COBAS TaqMan Analyzer
Code Information COBAS TaqMan Analyzer Serial Numbers: 381046; 381053; 391159; 391166; 391181; 371036; 391130; 391095; 381052; 391191; 391096; 381044; 391131; 381050; 381054; 391180; 381045; 391177; 391189; 381047; 381051; 381055; 391182; 391157; 391148; 391135; 391143; 391141; 391138; 391175; 391144; 391161; 391150; 391156.  
Recalling Firm/
Manufacturer
Roche Molecular Systems Inc
11 Franklin Ave
Belleville NJ 07109-3501
For Additional Information Contact Karen McCullough
908-253-7610
Manufacturer Reason
for Recall
Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
FDA Determined
Cause 2
Other
Action An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.
Quantity in Commerce 34
Distribution Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
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 = JJF and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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