Device Recall CoatACount TSH IRMA IKTSX with calibrator TSI3X Lot 035

Lots 742 and 743

Clinical Chemistry and Clinical Toxicology Devices

2

No

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,

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.