Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1540-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 30, 2018

Date Posted: May 9, 2018

Recall Number: Z-1540-2018

Event ID: 79593

Reason for Recall:

May produce erroneously low results from specific well sets.

Status: Terminated

Product Quantity: 6000

Code Information:

Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated