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www.fdanews.com/articles/70653-dade-behring-issues-voluntarily-recall-of-microscan-broth

Dade Behring Issues Voluntarily Recall of MicroScan Broth

April 4, 2005

Dade Behring has initiated a product recall of six lots of B1015-14 MicroScan Rapid Pos inoculum broth to prevent health risk to patients due to potential false antibiotic susceptibility results.

The possibility of inaccurate susceptibility results for a pathogen could lead a physician to prescribe incorrect or suboptimal therapy. In rare instances, this could result in severe or life-threatening consequences. By taking immediate action and notifying the 68 laboratories that received the recalled product, Dade Behring mitigated the risk to patients and to date no injuries have been reported as a result of this problem.

Dade Behring recommended that laboratories use an alternative method for susceptibility testing of Gram positive bacterial isolates (e.g., MicroScan Dried overnight Gram Positive panels), and review the susceptibility results obtained with the affected broth lots to determine if additional corrective actions should be taken in the affected institutions. Laboratories were instructed to contact physicians when appropriate. Dade Behring has notified the FDA and is working with them to coordinate activities for this Class I recall.