Devices

Device Recall CoatACount TSH IRMA IKTSX with calibrator TSI3X Lot 035

Model / Serial
Lots 742 and 743
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
Product Description
Immunoradiometric assay. || Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Manufacturer
Siemens Healthcare Diagnostics
1 Event
- Recall of Device Recall CoatACount TSH IRMA IKTSX with calibrator TSI3X Lot 035

Manufacturer

Siemens Healthcare Diagnostics

Manufacturer Address
Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
Source
USFDA

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