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Abbott Laboratories Diagnostic Div

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02 recall (Z-0516-06)Abbott Laboratories Diagnostic Div2006-02-14
Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 recall (Z-0383-06)Abbott Laboratories Diagnostic Div2006-01-11
Clinical Chemistry Immunoglobulin M, List Number 1E01-20 recall (Z-0384-06)Abbott Laboratories Diagnostic Div2006-01-11
Clinical Chemistry Prealbumin, List Number 1E02-20 recall (Z-0385-06)Abbott Laboratories Diagnostic Div2006-01-11
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 recall (Z-1400-05)Abbott Laboratories Diagnostic Div2005-08-24
Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 recall (Z-1377-04)Abbott Laboratories Diagnostic Div2004-08-17
AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South recall (Z-0165-04)Abbott Laboratories Diagnostic Div2004-07-20
AEROSET Phenobarbital, LN 1E08-01 recall (Z-0208-04)Abbott Laboratories Diagnostic Div2004-07-20
Clinical Chemistry Uric Acid; LN 7D76-20 recall (Z-0769-04)Abbott Laboratories Diagnostic Div2004-07-20
Clinical Chemistry Urea Nitrogen recall (Z-0550-04)Abbott Laboratories Diagnostic Div2004-02-26
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30. recall (Z-0355-04)Abbott Laboratories Diagnostic Div2004-01-16
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30 recall (Z-0240-04)Abbott Laboratories Diagnostic Div2003-12-18
Aeroset Direct HDL Reagent, LN 7D67-01 recall (Z-0803-03)Abbott Laboratories Diagnostic Div2003-05-09

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