FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: 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.
- Recall number
- Z-0972-2010
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-10-07
- Posted
- 2010-03-08
- Terminated
- 2010-12-10
- 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.
- Lot, serial or model codes
- Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.
- 510(k) numbers
- ["K020704"]
- PMA numbers
- not on file
- Product code
- LCD
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28