CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report
Siemens Advia Centaur¿ Vitamin D Total Assay SMN SMN recalled
Siemens Healthcare Diagnostics is recalling Siemens Advia Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test), distributed nationwide in the US. The recall was initiated on 5 Oct 2016 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-0398-2017
- FDA event ID
- 75394
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 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
| 5 Oct 2016 | Recall initiated by company | |
| 11 Nov 2016 | Classified by FDA | +37 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
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
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
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Where it was distributed
Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam
Questions about this recall
Is Siemens Advia Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Advia Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0398-2017.
Why was it recalled?
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
Which lots are affected?
All lot codes
Where was it sold?
Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam
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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