Z-0970-2010

Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no...

Name: Z-0970-2010 Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no...
Creator: Roche Diagnostics Operations, Inc.
Published: 2009-10-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-10-07 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2009-10-07. The reason FDA records is "A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0970-2010
Status: Terminated
Initiated: 2009-10-07
Posted: 2010-03-08
Terminated: 2010-12-10
Recalling firm: Roche Diagnostics GmbH
Product: 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.
Product code: LCD Enzyme Immunoassay, Gentamicin
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 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 in commerce: 13,187 of all products.
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers 15617800, 15622600, 15616900 and 15621900.

Product code LCD

K020704Class IIRoche Online GentamicinRoche Diagnostics Corp. / cleared 2002-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)