FDA recall Z-1588-2018

Product

Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

Reason for recall

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

Distribution

FL and France Spain Sweden United Kingdom Germany

Key facts

Status

Terminated

Initiation date

2018-02-26

Report date

2018-05-09

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1588-2018