Z-0401-2017Class III

Dimension Vista IRON Flex reagent cartridges

Name: Z-0401-2017 Dimension Vista IRON Flex reagent cartridges
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-08-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-08-25 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista IRON Flex reagent cartridges on 2016-08-25. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0401-2017
Classification: Class III
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-11-11
Terminated: 2017-12-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista IRON Flex reagent cartridges
Product code: JIY Photometric Method, Iron (Non-Heme)
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).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.
Quantity in commerce: 30,247 units
Distribution: Distributed Nationwide
Product codes and lots: Device Listing # D011391 Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD Exp Date 08-31-2016 - 07/19-2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-11
Z-0402-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-11

Product code JIY

K060264Class IDimension Iron Flex Reagent Cartridge (Iron-Df85)Dade Behring, Inc. / cleared 2006-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)