Roche Diagnostics Operations, Inc. Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. 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.
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
Lot Numbers 15622600, 15617800, 15616900 and 15816200.
Products Sold
Lot Numbers 15622600, 15617800, 15616900 and 15816200.
Roche Diagnostics Operations, Inc. is recalling Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 0 due to A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
Recommended Action
Per FDA guidance
Consignees 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026