Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0401-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Dimension Vista IRON Flex reagent cartridges

Product Classification:

Class III

Date Initiated: August 25, 2016

Date Posted: November 23, 2016

Recall Number: Z-0401-2017

Event ID: 75256

Reason for Recall:

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

Status: Terminated

Product Quantity: 30,247 units

Code Information:

Device Listing # D011391 Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD Exp Date 08-31-2016 - 07/19-2016.

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated