CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report
Dimension Vista LOCI Progesterone recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone, distributed nationwide in the US. The recall was initiated on 4 Jan 2017 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-1419-2017
- FDA event ID
- 76212
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2017
- FDA classified
- 9 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Jan 2017 | Recall initiated by company | |
| 9 Mar 2017 | Classified by FDA | +64 days |
| 15 Mar 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DHEA-S causes falsely elevated progesterone results.
Product as listed by the FDA
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
Where it was distributed
US Nationwide distribution including Puerto Rico
Questions about this recall
Why was it recalled?
DHEA-S causes falsely elevated progesterone results.
Which lots are affected?
16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA
Where was it sold?
US 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 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
3 other products · FDA event 76212This product is part of a recall event; the main page for the event is Immulite 2000 Progesterone recalled by Siemens Healthcare Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Immulite 2000 Progesterone recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Immulite/ Immulite 1000 Progesterone recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia Centaur Progesterone recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Other | Nationwide |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |