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Recall Observatory FDA recall evidence

Device product

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

Z-1668-2018

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-1668-2018

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: TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261

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.