CLASS III Device recall · Reported 23 Nov 2016 · FDA Enforcement Report
Dimension IRON Flex reagent cartridges recalled
Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges, distributed nationwide in the US. The recall was initiated on 25 Aug 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0402-2017
- FDA event ID
- 75256
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Aug 2016
- FDA classified
- 11 Nov 2016
- Reported
- 23 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Aug 2016 | Recall initiated by company | |
| 11 Nov 2016 | Classified by FDA | +78 days |
| 23 Nov 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dimension IRON Flex reagent cartridges
Where it was distributed
Distributed Nationwide
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017
Where was it sold?
Distributed Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 75256This product is part of a recall event; the main page for the event is Dimension Vista IRON Flex reagent cartridges recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Dimension Vista IRON Flex reagent cartridges recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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