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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 34 Results
510(K) Number: K980367
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ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laborat... 2 10/06/2017 Abbott Laboratories, Inc
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only.... 2 10/26/2015 Abbott Laboratories, Inc
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is inten... 2 07/22/2015 Abbott Laboratories
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and ... 2 06/27/2015 Abbott Laboratories
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It i... 2 06/08/2015 Abbott Laboratories
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affec... 2 09/11/2008 Abbott Laboratories, Inc
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064 3 05/24/2008 Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: ... 2 11/07/2007 Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected software:... 2 06/19/2007 Abbott Laboratories, Inc
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Lab... 3 01/18/2006 Abbott Laboratories, Inc
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