FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista IRON Flex reagent cartridges
- Recall number
- Z-0401-2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista IRON Flex reagent cartridges
- Status
- Terminated
- Initiated
- 2016-08-25
- Posted
- not on file
- Terminated
- 2017-12-01
- 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).
- 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
- 30,247 units
- Distribution
- Distributed Nationwide
- Lot, serial or model codes
- Device Listing # D011391 Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD Exp Date 08-31-2016 - 07/19-2016.
- 510(k) numbers
- ["K060264"]
- PMA numbers
- not on file
- Product code
- JIY
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28