CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
Immulite/Immulite 1000 Systems Androstenedione (Test recalled
Siemens Healthcare Diagnostics is recalling Immulite/Immulite 1000 Systems Androstenedione (Test Code And), distributed nationwide in the US. The recall was initiated on 20 Dec 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-1531-2014
- FDA event ID
- 67211
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2013
- FDA classified
- 30 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Dec 2013 | Recall initiated by company | |
| 30 Apr 2014 | Classified by FDA | +131 days |
| 7 May 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
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
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.
Where it was distributed
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.
Questions about this recall
Why was it recalled?
Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
Which lots are affected?
Lot Numbers 409 and above
Where was it sold?
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.
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
1 other product · FDA event 67211| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Immulite 2000/2000 XPi Systems Androstenedione (Test recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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