Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0402-2017)

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 IRON Flex reagent cartridges

Product Classification:

Class III

Date Initiated: August 25, 2016

Date Posted: November 23, 2016

Recall Number: Z-0402-2017

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: 38,230 cartridges

Code Information:

Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated