Recall -- Firm Press Release
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Dade Behring has Voluntarily Issued Nationwide Recall Of Microscan Rapid Pos Inoculum Broth
FOR IMMEDIATE RELEASE -- Deerfield, IL -- April 1, 2005 -- Dade Behring, the world's largest company solely dedicated to clinical diagnostics, on January 26, 2005, 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. Each laboratory was notified both by an overnight letter and either received a personal visit or a telephone call from Dade Behring to clarify actions to be taken by the laboratory regarding the product recall.
"Dade Behring's number one focus is on our customers, and we are deeply committed to providing quality products and resolving any customer concerns immediately," said Dave Edelstein, Chief Regulatory Officer. "The root cause has been identified to be a variation of the raw material in the broth manufactured for Dade Behring by a third party -- that can impact QC and clinical isolate performance. We have confirmed that each of our customers affected has been provided replacement product and should have no further concerns related to this recall. Additionally, Dade Behring is working on actions to prevent recurrence and has implemented increased quality control testing of this product to increase assurance of acceptability."
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 U.S. Food and Drug Administration and is working with them to coordinate activities for this Class I recall. Customers with questions may contact the Dade Behring MicroScan technical assistance center at 1-800-677-7226.