CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Dimension Vista¿ HbA1c recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Dimension Vista¿ HbA1c, distributed nationwide in the US. The recall was initiated on 14 Aug 2014 and the FDA has classified it as Class II.
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-0127-2015
- FDA event ID
- 69334
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2014
- FDA classified
- 24 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2014 | Recall initiated by company | |
| 24 Oct 2014 | Classified by FDA | +71 days |
| 5 Nov 2014 | 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
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
Product as listed by the FDA
Dimension Vista¿ HbA1c
Where it was distributed
Worldwide Distribution: US (nationwide) and country of: Canada.
Questions about this recall
Why was it recalled?
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
Which lots are affected?
catalog #K3105A, material #10470481, All in-date lots
Where was it sold?
Worldwide Distribution: US (nationwide) and country of: Canada.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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