Skip to content
Recall Observatory FDA recall evidence

Device product

ADVIA Centaur¿ Cyclosporine

Z-1687-2018

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-1687-2018

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: ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031

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