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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 11, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 09, 2004
Recall Number Z-1072-04
Recall Event ID 29380
Product Classification Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis - Product Code NDZ
Product Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
Code Information Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B 
Recalling Firm/
Manufacturer
Gen Probe Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Wayne Kvetkosky
858-410-8543
Manufacturer Reason
for Recall
Reduced stability
FDA Determined
Cause 2
Other
Action Firm notified all customers by fax and/or overnight letter on June 11, 2004. The notice indicated that users can continue to the MTD product provided that teh Specimen Processing positive cell controls are used according to package insert instructions and valid assay results are obtained. The affected MTD Enzyme Reagent will be replaced with a new lot of reagent.
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.
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