CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report
Advia Centaur Vitamin D Assay (100 tests) recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur Vitamin D Assay (100 tests), distributed nationwide in the US. The recall was initiated on 13 Mar 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-1119-2013
- FDA event ID
- 64610
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2013
- FDA classified
- 15 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Mar 2013 | Recall initiated by company | |
| 15 Apr 2013 | Classified by FDA | +33 days |
| 24 Apr 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Negative bias in patient samples for Vitamin D
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
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
Negative bias in patient samples for Vitamin D
Which lots are affected?
Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013
Where was it sold?
Nationwide Distribution.
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 64610| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Centaur Vitamin D Assay (500 tests) recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Advia Centaur Vitamin D Calibrator recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia Centaur Vitamin D Calibrator recalled | 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 |