Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The recall — FDA Z-1359-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Recall history in this database
Classification mix: Class II: 52, Class I: 41, Class III: 15.
Medical DeviceMay 22, 2019
Abbott Laboratories Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus recall — FDA Z-1362-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c recall — FDA Z-1356-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus recall — FDA Z-1355-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH recall — FDA Z-1357-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceApr 10, 2019
Abbott Laboratories CELL-DYN Emerald analyzer, REF 09H39-01 recall — FDA Z-1074-2019
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Class IIFDA: TerminatedAbbott Laboratories
FoodMar 18, 2015
Abbott Laboratories Similac Advance Complete Nutrition Infant Formula with Iron recall — FDA F-1409-2015
The firm received three consumer calls of product with Chinese labeling. After an internal investigation, the firm discovered that product manufactured for export to China was distributed…
Class IIFDA: TerminatedAbbott Laboratories
DrugJan 9, 2013
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle recall — FDA D-107-2013
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Class IIFDA: TerminatedAbbott Laboratories
DrugOct 3, 2012
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg recall — FDA D-1696-2012
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class IIFDA: TerminatedAbbott Laboratories
DrugOct 3, 2012
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg recall — FDA D-1695-2012
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class IIFDA: TerminatedAbbott Laboratories
DrugOct 3, 2012
Synthroid (levothyroxine sodium) Tablets USP, 50 mcg recall — FDA D-1694-2012
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class IIFDA: TerminatedAbbott Laboratories
DrugJun 27, 2012
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton recall — FDA D-1388-2012
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Class IIFDA: TerminatedAbbott Laboratories
Understanding this recall history
This page summarizes recall records in which the official source identifies Abbott Laboratories as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.