FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics: IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 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.
- Recall number
- Z-1532-2014
- Recalling firm
- Siemens Healthcare Diagnostics
- Product
- IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 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.
- Status
- Terminated
- Initiated
- 2013-12-20
- Posted
- 2014-04-30
- Terminated
- 2017-02-28
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated December 19, 2013, to its customers informing them that Siemens Healthcare Diagnostics has 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). The distribution of the customer communication began on 12/20/13 via FedEx (US). The letter described the product, problem and actions to be taken. Customers were instructed to take the following actions: - Please discuss this communication with your medical director. - Siemens recommends the use of Quality Control materials with at least two levels having concentrations less than 5.5 ng/mL. - Patient values of > 5.5 ng/mL should be verified using an alternate method. - and complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice within 30 days and fax to: CUSTOMER CARE CENTER at 302-631-7597. Field service personnel were sent a Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions. If you have any questions, please call 1-914-524-3074 or contact your Siemens Customer Care Center or your local Siemens technical support representative.
- Quantity
- 7741
- Distribution
- 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.
- Lot, serial or model codes
- Lot Numbers 314 and above
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CIZ
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28