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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro...
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2
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06/27/2015
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LifeHealth, LLC
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ICT Serum Calibrator REF 146-03.
For use in the calibration of the serum Sodium, Potassium, and ...
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2
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06/27/2015
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Abbott Laboratories
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StoneLight 30 Laser System (NS3000).
For use in surgical procedures using open, laparoscopic and ...
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2
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06/27/2015
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New Star Lasers, Inc.
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SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray tr...
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2
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06/27/2015
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Siemens Medical Solutions USA, Inc
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SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray t...
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2
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06/27/2015
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Siemens Medical Solutions USA, Inc
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Creatinine Plus ver. 2.
Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c syste...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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HDL-Cholesterol gen.3.
For the quantitative determination of high-density lipoprotein Cholesterol...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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HDL-Cholesterol plus gen.3.; and Small Supersized
Intended for use on COBAS Integra 800 and 400 p...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Lactate.
Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MO...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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LDL-Cholesterol gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the q...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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