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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS TaqMan

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  Class 2 Device Recall COBAS TaqMan see related information
Date Initiated by Firm March 06, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 on December 10, 2003
Recall Number Z-0917-03
Recall Event ID 25949
510(K)Number K012966  
Product Classification Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
Product COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Code Information All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
Recalling Firm/
Roche Molecular Systems Inc
11 Franklin Ave
Belleville NJ 07109
For Additional Information Contact
Manufacturer Reason
for Recall
A false positive result may be reported.
FDA Determined
Cause 2
Action Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
Quantity in Commerce 16
Distribution Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.
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.