Food, drugs, devices › Siemens Healthcare Diagnostics, Inc.

Device recall: Dimension Vista IRON Flex reagent cartridges

FDA enforcement event 75256 · Class III · initiated 25 Aug 2016 · status Terminated · terminated 1 Dec 2017

DeviceVoluntary: Firm initiated2 product recordsNewark, DE

Siemens Healthcare Diagnostics, Inc. (Newark, DE) initiated this device recall on 25 Aug 2016; FDA lists 2 product records under event 75256, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 1 Dec 2017. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc. has 333 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Siemens Healthcare Diagnostics, Inc., Newark, DE.

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)."

Distribution

"Distributed Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0401-2017	Dimension Vista IRON Flex reagent cartridges	30,247 units	Class III	Terminated	23 Nov 2016
Z-0402-2017	Dimension IRON Flex reagent cartridges	38,230 cartridges	Class III	Terminated	23 Nov 2016

Context

5%of 2016 device events are Class III1,232 events that year

2product records in this eventfirm median: 1

333events on this register for the firm

Other enforcement events for Siemens Healthcare Diagnostics, Inc.

Initiated	Product (first record)	Type	Class	Records
13 Jul 2026	Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL	Device	Class II	2
6 Jul 2026	Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic	Device	Class II	1
26 Jun 2026	Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL	Device	Class III	1
26 Jun 2026	Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL	Device	Class III	1
8 Jun 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.	Device	Class II	1
7 May 2026	Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay	Device	Class II	1
2 Apr 2026	epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;	Device	Class II	1
18 Mar 2026	Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.	Device	Class II	1
23 Feb 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;	Device	Class II	1
20 Jan 2026	Atellica CH Urine Albumin (UAlb). Material Number: 11537225	Device	Class II	1

All 333 events for Siemens Healthcare Diagnostics, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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)."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.