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Recall Observatory FDA recall evidence

Device product

Dimension IRON Flex reagent cartridges

Z-0402-2017

August 25, 2016

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 75256
Status
Terminated
Classification
Class III
Quantity
38,230 cartridges
Official record key
device-enforcement:Z-0402-2017

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

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).