Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
FDA device recall Z-1673-2018 · posted 2018-05-04 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- JLW
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Date initiated
- 2018-01-02
- Date posted
- 2018-05-04
- Date terminated
- 2023-02-10
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |