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Terminated

Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

FDA Recall Z-0918-2007 · Posted 2007-06-09

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeKLB
Date Initiated2007-04-05
Date Terminated2008-04-30
Product Quantity474 total (Z-0917-0918-2007)

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.

Firm 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.

Root Cause

Other

Distribution Pattern

International Distribution ONLY-Australia, Canada and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060853ONLINE TDM TOBRAMYCINRoche Diagnostics Corp. · 2006-06-09

Official Source

View FDA Recall →

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

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