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Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dime
Recalled April 10, 2013 · FDA recall Z-1049-2013 · Siemens Healthcare Diagnostics
Hazard
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent. · FDA Class II
Units
60,674
Sold at
Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Description
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
Product
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →