Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Reported: May 16, 2018 Initiated: January 2, 2018 #Z-1673-2018
Product Description
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1673-2018.
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