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Abbott Diagnostic International, Ltd.

24 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II a recall (Z-0297-2009)Abbott Diagnostic International, Ltd.2008-11-21
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that dete recall (Z-1566-2008)Abbott Diagnostic International, Ltd.2008-07-24
Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reag recall (Z-0928-2008)Abbott Diagnostic International, Ltd.2008-02-26
Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. Thi recall (Z-0929-2008)Abbott Diagnostic International, Ltd.2008-02-26
Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent s recall (Z-0930-2008)Abbott Diagnostic International, Ltd.2008-02-26
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), Fo recall (Z-0064-2008)Abbott Diagnostic International, Ltd.2007-11-03
Abbott AxSYM System Digoxin III Reagent Pack recall (Z-1202-2007)Abbott Diagnostic International, Ltd.2007-08-29
AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F recall (Z-1185-2007)Abbott Diagnostic International, Ltd.2007-08-22
AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5m recall (Z-1186-2007)Abbott Diagnostic International, Ltd.2007-08-22
XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product L recall (Z-1187-2007)Abbott Diagnostic International, Ltd.2007-08-22
XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5 recall (Z-1188-2007)Abbott Diagnostic International, Ltd.2007-08-22
ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUS recall (Z-1096-2007)Abbott Diagnostic International, Ltd.2007-07-24
Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the followi recall (Z-1097-2007)Abbott Diagnostic International, Ltd.2007-07-24
ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following component recall (Z-1098-2007)Abbott Diagnostic International, Ltd.2007-07-24
TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro di recall (Z-1056-2007)Abbott Diagnostic International, Ltd.2007-07-20
AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Micr recall (Z-1067-2007)Abbott Diagnostic International, Ltd.2007-07-12
AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Micr recall (Z-1068-2007)Abbott Diagnostic International, Ltd.2007-07-12
IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one recall (Z-1069-2007)Abbott Diagnostic International, Ltd.2007-07-12
Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent cont recall (Z-1070-2007)Abbott Diagnostic International, Ltd.2007-07-12
IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is compose recall (Z-0958-2007)Abbott Diagnostic International, Ltd.2007-07-03
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 recall (Z-0117-2007)Abbott Diagnostic International, Ltd.2006-11-17
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. recall (Z-0023-2007)Abbott Diagnostic International, Ltd.2006-10-12
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. recall (Z-0024-2007)Abbott Diagnostic International, Ltd.2006-10-12
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use. recall (Z-0025-2007)Abbott Diagnostic International, Ltd.2006-10-12

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