CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report
Immulite 2000 EstradiolTest recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Immulite 2000 EstradiolTest Code E2, distributed nationwide in the US. The recall was initiated on 13 Jan 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-1243-2016
- FDA event ID
- 73052
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2016
- FDA classified
- 24 Mar 2016
- Reported
- 30 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Jan 2016 | Recall initiated by company | |
| 24 Mar 2016 | Classified by FDA | +71 days |
| 30 Mar 2016 | 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
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Product as listed by the FDA
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
Where it was distributed
Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
Questions about this recall
Why was it recalled?
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Which lots are affected?
All lots
Where was it sold?
Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
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 73052| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Siemens Advia Centaur Enhance Estradiol Test recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Immulite 1000 Estradiol Test recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Dimension Vista LOCI Estradiol Test recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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|---|---|---|---|---|---|
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