Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1587-2018)

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:

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

Product Classification:

Class II

Date Initiated: February 26, 2018

Date Posted: May 9, 2018

Recall Number: Z-1587-2018

Event ID: 79683

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

Status: Terminated

Product Quantity: N/A

Code Information:

UDI 00630414002439

Distribution Pattern:

FL and France Spain Sweden United Kingdom Germany

Voluntary or Mandated:

Voluntary: Firm initiated