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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Online TDM Tobramycin

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  Class 2 Device Recall Roche Online TDM Tobramycin see related information
Date Initiated by Firm April 05, 2007
Date Posted June 09, 2007
Recall Status1 Terminated 3 on April 30, 2008
Recall Number Z-0918-2007
Recall Event ID 37795
510(K)Number K060853  
Product Classification Radioimmunoassay, tobramycin - Product Code KLB
Product Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)
Code Information Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
317-521-7252
Manufacturer Reason
for Recall		 Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.
FDA Determined
Cause 2		 Other
Action Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.
Quantity in Commerce 474 total (Z-0917-0918-2007)
Distribution International Distribution ONLY-Australia, Canada and Germany.
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 = KLB and Original Applicant = ROCHE DIAGNOSTICS CORP.
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