CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
User Defined Method Flex Assignment/Siemens Dimension Vista recalled
Siemens Healthcare Diagnostics is recalling User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500, distributed nationwide in the US. The recall was initiated on 7 Oct 2013 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-0851-2014
- FDA event ID
- 66585
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2013
- FDA classified
- 28 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Oct 2013 | Recall initiated by company | |
| 28 Jan 2014 | Classified by FDA | +113 days |
| 5 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Where it was distributed
USA (nationwide) Distribution including Puerto Rico.
Questions about this recall
Is User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 recalled?
Yes. Siemens Healthcare Diagnostics recalled User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 on 7 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0851-2014.
Why was it recalled?
When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
Which lots are affected?
Material numbers 10284473, 10488224, 10444801, and 10444802.
Where was it sold?
USA (nationwide) Distribution including Puerto Rico.
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 21 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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