Z-1669-2018 Class II Terminated
FDA device recall Z-1669-2018 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¿ Free Thyroxine (FT4L) 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
FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1669-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026