| Class 2 Device Recall COBAS TaqMan |  |
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
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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/ Manufacturer |
Roche Molecular Systems Inc 11 Franklin Ave Belleville NJ 07109
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For Additional Information Contact | 800-526-1247 |
Manufacturer Reason for Recall | A false positive result may be reported. |
FDA Determined Cause 2 | Other |
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 |
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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 = JJF
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