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Recall Observatory FDA recall evidence

Device product

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Z-1669-2018

January 02, 2018

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 79505
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1669-2018

Official wording

Reason: The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Code information: FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254

Distribution pattern: Nationwide and Canada, Mexico, and Thailand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.