Z-1531-2014Class II

IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit...

Name: Z-1531-2014 IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit...
Creator: Siemens Healthcare Diagnostics
Published: 2013-12-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-12-20 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products... on 2013-12-20. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1531-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-20
Posted: 2014-04-30
Terminated: 2017-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: CIZ Radioimmunoassay, Androstenedione
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 892
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.
Product codes and lots: Lot Numbers 409 and above

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1531-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1531-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-30
Z-1532-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-30

Product code CIZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)