Abbott Laboratories, Inc
22 recalls on record · Latest: Mar 23, 2022
FDA Devices Moderate Mar 23, 2022
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use…
FDA Devices Moderate Aug 18, 2021
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis sc…
FDA Devices Moderate Apr 15, 2020
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photome…
FDA Devices Moderate Oct 2, 2019
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
FDA Devices Moderate Jul 31, 2019
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific an…
FDA Devices Moderate Jul 31, 2019
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sam…
FDA Devices Moderate Jul 31, 2019
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to ap…
FDA Devices Moderate Jul 31, 2019
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sam…
FDA Devices Moderate Jul 31, 2019
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sam…
FDA Devices Moderate Jul 31, 2019
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apol…
FDA Devices Moderate May 15, 2019
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quanti…
FDA Devices Moderate Apr 17, 2019
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. T…
FDA Devices Moderate Apr 17, 2019
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. …
FDA Devices Moderate Apr 10, 2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
FDA Devices Moderate Mar 13, 2019
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
FDA Devices Moderate Aug 1, 2018
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM…
FDA Devices Moderate Mar 14, 2018
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvet…
FDA Devices Moderate Mar 14, 2018
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvett…
FDA Devices Moderate Nov 29, 2017
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
FDA Devices Moderate Oct 18, 2017
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are …
FDA Devices Moderate Oct 23, 2013
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
FDA Devices Moderate Apr 24, 2013