Z-1688-2018 Class II Terminated
FDA device recall Z-1688-2018 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
ADVIA Centaur¿ DHEA-SO4
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
ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1688-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026