Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
- Recall date
- January 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1668-2018
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- Nationwide and Canada, Mexico, and Thailand
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
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