Recall Z-0972-2010
Roche Diagnostics Operations, Inc. · initiated October 7, 2009
Product
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.
Codes / lots: Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.
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: 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.
Details
- Recall number
- Z-0972-2010
- Initiated
- October 7, 2009
- Posted by FDA
- March 8, 2010
- Terminated
- December 10, 2010
- Product code
- LCD – Enzyme Immunoassay, Gentamicin
- Quantity
- 13,187 of all products.
- Distribution
- Nationwide Distribution.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0970-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | 10/07/2009Terminated |
| Z-0971-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | 10/07/2009Terminated |