Device Recall CoatACount TSH IRMA IKTS5 with calibrator TSI3X Lot 035

Lots 831 and 832

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.