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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CPBNPD)

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  Class 2 Device Recall Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CPBNPD) see related information
Date Initiated by Firm April 03, 2006
Date Posted May 19, 2006
Recall Status1 Terminated 3 on August 07, 2006
Recall Number Z-0885-06
Recall Event ID 35112
510(K)Number K043476  
Product Classification Test, Natriuretic Peptide - Product Code NBC
Product Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro diagnostic.
Code Information Lot # 916065002
Recalling Firm/
Manufacturer		 Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Fran Dillon
302-631-6951
Manufacturer Reason
for Recall		 Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
FDA Determined
Cause 2		 Other
Action Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.
Quantity in Commerce 1 carton of 5 DilPaks
Distribution Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
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 = NBC and Original Applicant = DADE BEHRING, INC.
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