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Terminated

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.

FDA Recall Z-0972-2010 · Posted 2010-03-08

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeLCD
Date Initiated2009-10-07
Date Terminated2010-12-10
Product Quantity13,187 of all products.

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp. · 2002-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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