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Abbott Laboratories HPD/ADD

22 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M recall (Z-1130-03)Abbott Laboratories HPD/ADD2003-08-13
IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL recall (Z-1131-03)Abbott Laboratories HPD/ADD2003-08-13
Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrato recall (Z-1132-03)Abbott Laboratories HPD/ADD2003-08-13
AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Canc recall (Z-1047-03)Abbott Laboratories HPD/ADD2003-07-24
Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single u recall (Z-0955-03)Abbott Laboratories HPD/ADD2003-06-27
I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, recall (Z-0956-03)Abbott Laboratories HPD/ADD2003-06-27
Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laborato recall (Z-0957-03)Abbott Laboratories HPD/ADD2003-06-27
I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; recall (Z-0958-03)Abbott Laboratories HPD/ADD2003-06-27
Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, No recall (Z-0959-03)Abbott Laboratories HPD/ADD2003-06-27
96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44 recall (Z-1134-03)Abbott Laboratories HPD/ADD2003-06-27
96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 4 recall (Z-1135-03)Abbott Laboratories HPD/ADD2003-06-27
75-1650 Drip Chambers .138rr; Abbott, Ashland, Ohio 44805; 800 drip chambers per case; Abb recall (Z-1136-03)Abbott Laboratories HPD/ADD2003-06-27
T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Ir recall (Z-0934-03)Abbott Laboratories HPD/ADD2003-06-17
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Se recall (Z-0936-03)Abbott Laboratories HPD/ADD2003-06-17
LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Si recall (Z-0914-03)Abbott Laboratories HPD/ADD2003-06-05
LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 In recall (Z-0915-03)Abbott Laboratories HPD/ADD2003-06-05
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott La recall (Z-0801-03)Abbott Laboratories HPD/ADD2003-05-09
Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbo recall (Z-0782-03)Abbott Laboratories HPD/ADD2003-04-24
Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), recall (Z-0726-03)Abbott Laboratories HPD/ADD2003-04-16
Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bott recall (Z-0679-03)Abbott Laboratories HPD/ADD2003-03-26
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactiv recall (Z-0680-03)Abbott Laboratories HPD/ADD2003-03-26
IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode recall (Z-0681-03)Abbott Laboratories HPD/ADD2003-03-26

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