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Device Recall Dimension Thyroid Stimulating Hormone (TSHL) Flex
Model / Serial
TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada, Mexico, and Thailand
Product Description
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of Device Recall Dimension Thyroid Stimulating Hormone (TSHL) Flex
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Manufacturer
Siemens Healthcare Diagnostics, Inc.
Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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