Roche/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.
Hazard
A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
What You Should Do
Remedy
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.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
Roche/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 dete
- Brand
- Roche Diagnostics Operations, Inc.
- UPC
- Lot Numbers 15617800, 15622600, 15616900 and 15621900.
Units Affected
13,187 of all products.