FDA recall Z-1540-2018

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.

Reason for recall

May produce erroneously low results from specific well sets.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-30

Report date

2018-05-09

Termination date

2019-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2018