FDA-Device2013-01-16Class III
Immunoradiometric assay.
Siemens Healthcare Diagnostics
Hazard
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)
Sold states
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,
Affected count
Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Immunoradiometric assay.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0647-2013Don't want to check this manually?
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