medical Class II Updated 2018-05-09

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension

Recalled Product

Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.


Hazard / Issue

May produce erroneously low results from specific well sets.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
View official government recall

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