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Abbott Laboratories HPD/ADD/GPRD

43 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and l recall (Z-1498-04)Abbott Laboratories HPD/ADD/GPRD2004-09-30
XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma g recall (Z-1474-04)Abbott Laboratories HPD/ADD/GPRD2004-09-18
ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott recall (Z-1452-04)Abbott Laboratories HPD/ADD/GPRD2004-09-14
Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69- recall (Z-0277-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-10 recall (Z-0278-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number recall (Z-0279-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-572 recall (Z-0280-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott L recall (Z-0297-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Pentalumen TD Thermodilution Catheter, Sterile recall (Z-0305-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrato recall (Z-0353-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, L recall (Z-0361-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Cont recall (Z-0362-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual recall (Z-0363-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) recall (Z-0364-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with pro recall (Z-0365-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human album recall (Z-0366-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Mediu recall (Z-0367-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each recall (Z-0368-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate recall (Z-0369-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx recall (Z-0370-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with huma recall (Z-0371-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reage recall (Z-0372-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, recall (Z-0723-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), A recall (Z-0781-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park recall (Z-0782-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 tes recall (Z-1048-04)Abbott Laboratories HPD/ADD/GPRD2004-07-20
18 Gauge thin wall needle as part of a Central Venous Catheter Kit recall (Z-0543-04)Abbott Laboratories HPD/ADD/GPRD2004-02-24
TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnosti recall (Z-0507-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Pa recall (Z-0508-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Par recall (Z-0509-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park recall (Z-0510-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60 recall (Z-0511-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 tes recall (Z-0318-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0319-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0320-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0321-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0322-04)Abbott Laboratories HPD/ADD/GPRD2004-01-10
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reac recall (Z-0293-04)Abbott Laboratories HPD/ADD/GPRD2004-01-06
IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratori recall (Z-0230-04)Abbott Laboratories HPD/ADD/GPRD2003-12-17
Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; A recall (Z-0209-04)Abbott Laboratories HPD/ADD/GPRD2003-12-11
IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Ca recall (Z-0063-04)Abbott Laboratories HPD/ADD/GPRD2003-10-24
AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for recall (Z-1218-03)Abbott Laboratories HPD/ADD/GPRD2003-09-11
IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL recall (Z-1129-03)Abbott Laboratories HPD/ADD/GPRD2003-08-13

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