Z-0868-2014Class II

T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and...

Name: Z-0868-2014 T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and...
Creator: Siemens Healthcare Diagnostics
Published: 2013-08-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an... on 2013-08-27. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0868-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-27
Posted: 2014-01-30
Terminated: 2017-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall Letters (dated 8/27/13) and Field Recall Effectiveness Check Forms were sent to the affected customers (starting on 8/27/13) informing them to discontinue use of and discard the IMMULITE Free T3 reagent kit lots. Customers were instructed to contact their local Siemens representative for assistance. Customers are requested to complete and return the Effectiveness Check Form included with the recall letter within thirty (30) days.
Quantity in commerce: 4695 kits in total
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.
Product codes and lots: Lot Numbers 737, 738, 739, 740, 741, 742, 743

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0868-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0868-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

Product code CDP

K974634Class IIImmulite Free T3Diagnostic Products Corp. / cleared 1998-01-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)