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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Total BhCG Reagent

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  Class 2 Device Recall AxSYM Total BhCG Reagent see related information
Date Initiated by Firm April 10, 2007
Date Posted July 12, 2007
Recall Status1 Terminated 3 on February 14, 2012
Recall Number Z-1068-2007
Recall Event ID 37920
510(K)Number K935673  
Product Classification B-hCG In Vitro Diagnostic - Product Code JHI
Product AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-22. 100 Tests. For In Vitro Diagnostic Use.
Code Information 46329Q100, 47118Q100, 48063Q100, 48064Q100, 49341Q100, 49559Q100.
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
30 Bo Cruce Davila
Barceloneta PR 00617-3009
For Additional Information Contact Customer Support
877-422-2688
Manufacturer Reason
for Recall		 An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.
FDA Determined
Cause 2		 Other
Action The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
Quantity in Commerce 13716 kits
Distribution Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.
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 = JHI and Original Applicant = ABBOTT LABORATORIES
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