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Terminated

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.

FDA Recall Z-0868-2014 · Posted 2014-01-30

Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeCDP
Date Initiated2013-08-27
Date Terminated2017-02-28
Product Quantity4695 kits in total

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974634IMMULITE FREE T3Diagnostic Products Corp. · 1998-01-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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