Recall Z-1688-2018— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-01-02, terminated 2023-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Centaur¿ DHEA-SO4. 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-02
- Terminated
- 2023-02-10
- Firm location
- Tarrytown, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.