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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi cobas ONLINE TDM Gentamicin

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 Class 2 Device Recall Roche/Hitachi cobas ONLINE TDM Gentamicinsee related information
Date Initiated by FirmOctober 07, 2009
Date PostedMarch 08, 2010
Recall Status1 Terminated 3 on December 10, 2010
Recall NumberZ-0970-2010
Recall Event ID 53546
510(K)NumberK020704 
Product Classification Enzyme immunoassay, gentamicin - Product Code LCD
ProductRoche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
Code Information Lot Numbers 15617800, 15622600, 15616900 and 15621900.
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
FDA Determined
Cause 2		Other
ActionConsignees were notified by recall letter dated October 7, 2009. The letter described the affected products, issue and instructed consignees to immediately discontinue use of the products. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in the recall letter.
Quantity in Commerce13,187 of all products.
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LCD
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