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

FDA device recall Z-0868-2014 · posted 2014-01-30 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

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.

Action taken

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

Status

Terminated

Product code

CDP

Quantity affected

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,

Date initiated

2013-08-27

Date posted

2014-01-30

Date terminated

2017-02-28

Location

Tarrytown, NY

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