Reported May 16, 2018 · Terminated
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
- Lot codes and dates
- TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524
- Lot codes
EB7276EC7298EA7318EB7346EC7346EA8012EA8033EA8051EC8080EB8107EB8121EA8143EB8143EA8177EB8177EB8199EA8223EA8241EA8261
- Amount recalled
- N/A
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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