—#85816

Product

Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. 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.

FDA product code: LCD — Enzyme Immunoassay, Gentamicin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K020704
Affected lot / code info: Lot Numbers 15622600, 15617800, 15616900 and 15816200.

Why it was recalled

A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-10-07
Posted by FDA: 2010-03-08
Terminated: 2010-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.