Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190
FDA device recall Z-0970-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCD
- Quantity affected
- 13,187 of all products.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-10-07
- Date posted
- 2010-03-08
- Date terminated
- 2010-12-10
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE ONLINE GENTAMICIN (K020704) | Roche Diagnostics Corp. | 2002-07-12 |