Class 2 Device Recall Dade Behring

• Date Initiated by Firm: September 27, 2006
• Date Posted: December 05, 2006
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-0247-2007
• Recall Event ID: 36600
• 510(K)Number: K820299
• Product Classification: in vitro diagnostic - Product Code LIE
• Product: Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D
• Code Information: Lot Numbers: 20071127, 20071128
• FEI Number: 2919016
• Recalling Firm/ Manufacturer: Dade Behring, Inc.; 2040 Enterprise Blvd; West Sacramento CA 95691-3427
• Manufacturer Reason for Recall: Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
• FDA Determined Cause: Other
• Action: On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.
• Quantity in Commerce: 828 units
• Distribution: Worldwide, including USA, China, and Germany.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LIE