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Abbott Laboratories

140 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laborator recall (Z-1028-2007)Abbott Laboratories2007-07-11
AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laborat recall (Z-1029-2007)Abbott Laboratories2007-07-11
AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Labor recall (Z-1030-2007)Abbott Laboratories2007-07-11
AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Labora recall (Z-1031-2007)Abbott Laboratories2007-07-11
AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott Lab recall (Z-1032-2007)Abbott Laboratories2007-07-11
AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laborat recall (Z-1033-200)Abbott Laboratories2007-07-11
AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott Labora recall (Z-1034-2007)Abbott Laboratories2007-07-11
AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laborat recall (Z-1035-2007)Abbott Laboratories2007-07-11
AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Lab recall (Z-1036-2007)Abbott Laboratories2007-07-11
AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott Labora recall (Z-1037-2007)Abbott Laboratories2007-07-11
AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Labo recall (Z-1038-2007)Abbott Laboratories2007-07-11
AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Labor recall (Z-1039-2007)Abbott Laboratories2007-07-11
AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laborator recall (Z-1040-2007)Abbott Laboratories2007-07-11
ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottle recall (Z-0728-2007)Abbott Laboratories2007-04-07
CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by recall (Z-0706-2007)Abbott Laboratories2007-04-03
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed recall (Z-0708-2007)Abbott Laboratories2007-04-03
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured b recall (Z-0640-2007)Abbott Laboratories2007-03-17
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured b recall (Z-0639-2007)Abbott Laboratories2007-03-16
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. Li recall (Z-0565-2007)Abbott Laboratories2007-03-01
Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN h recall (Z-0246-2007)Abbott Laboratories2006-12-05
i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. recall (Z-1171-06)Abbott Laboratories2006-06-22
CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer recall (Z-0527-06)Abbott Laboratories2006-02-16
Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08 recall (Z-0269-06)Abbott Laboratories2005-12-06
Fleixiflo Quantum Enteral Pump. recall (Z-0145-06)Abbott Laboratories2005-11-16
10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener recall (Z-0960-05)Abbott Laboratories2005-07-07
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time recall (Z-0912-05)Abbott Laboratories2005-06-21
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for End recall (Z-0327-05)Abbott Laboratories2004-12-21
18 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener S recall (Z-0328-05)Abbott Laboratories2004-12-21
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for End recall (Z-0329-05)Abbott Laboratories2004-12-21
18 French Ross Flexiflo Over the Guidewire Gastrostomy Basic Kit with T-Fasteners for Endo recall (Z-0330-05)Abbott Laboratories2004-12-21
18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic recall (Z-0331-05)Abbott Laboratories2004-12-21
18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set (list recall (Z-0332-05)Abbott Laboratories2004-12-21
22 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring T recall (Z-0333-05)Abbott Laboratories2004-12-21
20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for recall (Z-0334-05)Abbott Laboratories2004-12-21
20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed recall (Z-0335-05)Abbott Laboratories2004-12-21
20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper ( recall (Z-0336-05)Abbott Laboratories2004-12-21
20 French Flexiflo Inverta-PEG Pull Technique Basic Gastrostomy KIt with Roll-Tip Bumper ( recall (Z-0337-05)Abbott Laboratories2004-12-21
10 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastner Se recall (Z-0338-05)Abbott Laboratories2004-12-21
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73 recall (Z-0648-03)Abbott Laboratories2003-03-13
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Numbe recall (Z-0632-03)Abbott Laboratories2003-03-12
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