FDA-Device2013-04-03Class III
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Siemens Healthcare Diagnostics, Inc.
Hazard
Correlation slope bias and accuracy shift
Sold states
Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
Affected count
1985 cartons
Manufactured in
511 Benedict Avenue, Tarrytown, NY, United States
Products
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0988-2013Don't want to check this manually?
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