Z-0917-2007

Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No...

Name: Z-0917-2007 Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No...
Creator: Roche Diagnostics Corp.
Published: 2007-04-05
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-04-05 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United... on 2007-04-05. The reason FDA records is "Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0917-2007
Status: Terminated
Initiated: 2007-04-05
Posted: 2007-06-09
Terminated: 2008-04-30
Recalling firm: Roche Diagnostics GmbH
Product: Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)
Product code: KLB Radioimmunoassay, Tobramycin
Reason for recall: Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.
FDA root cause: Other
Action: Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.
Quantity in commerce: 474 total (Z-0917-0918-2007)
Distribution: International Distribution ONLY-Australia, Canada and Germany.
Product codes and lots: Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.

Product code KLB

K060853Class IIOnline Tdm TobramycinRoche Diagnostics Corp. / cleared 2006-06-09

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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)