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U.S. Department of Health and Human Services

Class 1 Device Recall MicroScan

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  Class 1 Device Recall MicroScan see related information
Date Initiated by Firm February 07, 2005
Date Posted April 06, 2005
Recall Status1 Terminated 3 on July 05, 2005
Recall Number Z-0668-05
Recall Event ID 31125
PMA Number P870049 
Product Classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
Product MicroScan¿ Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
Code Information Lot Nos.:  050905A-1,  051005A-1,  051605A-1,  051705A-1,  052305A-1,  052805B-1  
Recalling Firm/
Manufacturer		 Dade Behring
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact Jose Untalan
916-374-3285
Manufacturer Reason
for Recall		 There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
FDA Determined
Cause 2		 Other
Action The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.
Quantity in Commerce 324 boxes
Distribution 71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.
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.
PMA Database PMAs with Product Code = LON and Original Applicant = DADE INTL., INC.
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