Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. 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.
This recall has been terminated (originally issued March 8, 2010).
- Recall Initiated
- October 7, 2009
- Posted
- March 8, 2010
- Terminated
- December 10, 2010
- Recall Number
- Z-0972-2010
- Quantity
- 13,187 of all products.
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.
Root Cause
Other
Action Taken
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.
More recalls by Roche Diagnostics Operations, Inc.
cobas pro integrated solutions with cobas c 503 analytical units:
cobas pro sample supply unit, mat...
Feb 27, 2026
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated m...
Jan 2, 2026
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/70...
Nov 19, 2024