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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66055

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 27, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- 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.

Z-0867-2014
Recall number
Z-0867-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Quantity
2201 kits in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers 353, 354

Distribution pattern

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.

device · product 2 of 2

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.

Z-0868-2014
Recall number
Z-0868-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Quantity
4695 kits in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers 737, 738, 739, 740, 741, 742, 743

Distribution pattern

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.