Recall Z-0970-2010 ยท LCD Enzyme Immunoassay, Gentamicin
Roche Diagnostics Operations, Inc.
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.
| Date | Mar 8, 2010 (initiated Oct 7, 2009) |
| Status | Terminated |
| Reason | A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient. |
| Root cause | Other |
| Action | 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. |
| Quantity | 13,187 of all products. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020704 | ROCHE ONLINE GENTAMICIN Roche Diagnostics Corp., Jul 12, 2002 |