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U.S. Department of Health and Human Services

Class 2 Device Recall Clearview Simplify

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  Class 2 Device Recall Clearview Simplify see related information
Date Initiated by Firm February 15, 2007
Date Posted March 13, 2007
Recall Status1 Terminated 3 on May 08, 2007
Recall Number Z-0594-2007
Recall Event ID 37356
510(K)Number K993276  
Product Classification D-dimer, in vitro diagnostic - Product Code GHH
Product Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.
Product No. 61100KVC
10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide
10 plastic pipettes
Wampole Laboratories
Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
Code Information Kit lot number: PX018A Test device batch number: 682-024 Catalog Number: 6100KVC Expiration date: 3/2008
Recalling Firm/
Manufacturer		 Inverness Medical Professional Diagnostics
2 Research Way
Princeton NJ 08540-6628
For Additional Information Contact Katrina Fielder
609-627-8038
Manufacturer Reason
for Recall		 Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
FDA Determined
Cause 2		 Other
Action Recall notification letters were sent to all customers on 2/14/07 by first class mail.
Quantity in Commerce 382 kits
Distribution Worldwide, including USA, Puerto Rico, and Canada.
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 = AGEN BIOMEDICAL LTD.
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