medical Class II Updated 2019-08-14

Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR

Recalled Product

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

Hazard / Issue

Negative Bias with Lot EA9227.

Issued by

FDA

Affected States: AK, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OK, OR, SD, TN, TX, VA, VT, WA, WI

Lot/Code Info: Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840

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