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 |
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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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