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U.S. Department of Health and Human Services

Class 2 Device Recall Dade Behring

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  Class 2 Device Recall Dade Behring see related information
Date Initiated by Firm September 27, 2006
Date Posted December 05, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = 3M COMPANY
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