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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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Z-1931-2015 - Uric Acid plus ver.2
In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus syst...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1930-2015 - Triglycerides/Glycerol Blanked.
In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1929-2015 - Triglycerides GPO.
In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR 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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Z-1926-2015 - Lactate.
Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in pl...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1928-2015 - LDL-Cholesterol plus gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1927-2015 - LDL-Cholesterol gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1925-2015 - HDL-Cholesterol plus gen.3.; and Small Supersized
Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol c...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1924-2015 - HDL-Cholesterol gen.3.
For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1922-2015 - Creatinine Plus.
Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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Z-1923-2015 - Creatinine Plus ver. 2.
Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
...
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2
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06/27/2015
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Roche Diagnostics Operations, Inc.
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