Z-1687-2018 Class II Terminated
FDA device recall Z-1687-2018 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¿ Cyclosporine
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¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1687-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026