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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K964020
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Product Description
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FDA Recall
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AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, A... 2 07/11/2007 Abbott Laboratories
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 3 01/10/2004 Abbott Laboratories HPD/ADD/GPRD
AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Ab... 3 01/10/2004 Abbott Laboratories HPD/ADD/GPRD
CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 3 01/10/2004 Abbott Laboratories HPD/ADD/GPRD
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