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Abbott Health Products, Inc.

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDx recall (Z-0624-06)Abbott Health Products, Inc.2006-03-15
AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle o recall (Z-0893-05)Abbott Health Products, Inc.2005-06-16
IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of recall (Z-0894-05)Abbott Health Products, Inc.2005-06-16
IMx HAVAB Controls In Vitro Test recall (Z-0660-05)Abbott Health Products, Inc.2005-03-29
IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Ne recall (Z-0217-05)Abbott Health Products, Inc.2004-11-20
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 recall (Z-0006-05)Abbott Health Products, Inc.2004-10-05
AxSYM Total B-hCG Reagent Pack recall (Z-1436-04)Abbott Health Products, Inc.2004-09-02
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 recall (Z-1229-04)Abbott Health Products, Inc.2004-07-28
AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tric recall (Z-0323-04)Abbott Health Products, Inc.2004-01-10
ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricycli recall (Z-0324-04)Abbott Health Products, Inc.2004-01-10
TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/T recall (Z-0325-04)Abbott Health Products, Inc.2004-01-10
AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: AxSYM Abbo recall (Z-0689-03)Abbott Health Products, Inc.2003-03-29
ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx, Abbott recall (Z-0690-03)Abbott Health Products, Inc.2003-03-29
TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following lab recall (Z-0691-03)Abbott Health Products, Inc.2003-03-29
AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories recall (Z-0627-03)Abbott Health Products, Inc.2003-03-06

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Every clearance here is in the API, with alerts when new ones post.