Recall Z-1668-2018 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge
| Date | May 4, 2018 (initiated Jan 2, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | 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 |
| Distribution | Nationwide and Canada, Mexico, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART Siemens Healthcare Diagnostics, Inc., Nov 26, 2014 |