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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-1920-2015 - Cholesterol CHOD-PAP.
In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol 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-1921-2015 - Cholesterol Gen.2.
The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and co...
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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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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-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-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-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-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-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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