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U.S. Department of Health and Human Services

Class 2 Device Recall Dade Fibrin(ogen) Degradation Products (FDP) Dectection Set

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  Class 2 Device Recall Dade Fibrin(ogen) Degradation Products (FDP) Dectection Set see related information
Date Initiated by Firm June 21, 2005
Date Posted July 22, 2005
Recall Status1 Terminated 3 on May 01, 2006
Recall Number Z-1040-05
Recall Event ID 32537
510(K)Number K872360  
Product Classification Fibrin Split Products - Product Code GHH
Product Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
Code Information Lot number P152010 exp 4/30/06.
Recalling Firm/
Manufacturer		 Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Donna A. Wolf
302-631-0384
Manufacturer Reason
for Recall		 positive control shows weak agglutination reaction
FDA Determined
Cause 2		 Other
Action The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
Quantity in Commerce 364 kits
Distribution The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
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 = GHH and Original Applicant = AMERICAN DADE
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