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Recall Observatory FDA recall evidence

Device product

Dimension Vista IRON Flex reagent cartridges

Z-0401-2017

August 25, 2016

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 75256
Status
Terminated
Classification
Class III
Quantity
30,247 units
Official record key
device-enforcement:Z-0401-2017

Official wording

Reason: 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).

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).