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Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for th
Recalled April 3, 2013 · FDA recall Z-0988-2013 · Siemens Healthcare Diagnostics
Hazard
Correlation slope bias and accuracy shift · FDA Class III
Units
1985 cartons
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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.
Description
Correlation slope bias and accuracy shift
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →