Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative me...
FDA Recall #Z-0646-2013 — Class III — November 28, 2012
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.
Reason for Recall
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
Recalling Firm
Siemens Healthcare Diagnostics — Tarrytown, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)
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,
Code Information
Lots 969 and 970
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated