CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report
Advia Centaur Progesterone recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Advia Centaur 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-1418-2017
- 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
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
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?
SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277; SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277; SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276
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 | Dimension Vista LOCI Progesterone recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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