—#51547

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)

FDA product code: KLB — Radioimmunoassay, Tobramycin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K060853
Affected lot / code info: Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: International Distribution ONLY-Australia, Canada and Germany.

Timeline

Recall initiated: 2007-04-05
Posted by FDA: 2007-06-09
Terminated: 2008-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.