Z-1668-2018 Class II Terminated
FDA device recall Z-1668-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Jan 2, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Feb 10, 2023).
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Jan 2, 2018
- Termination Date
- Feb 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Reason for Recall
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.
Distribution Pattern
Nationwide and Canada, Mexico, and Thailand
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1668-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026