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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

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.
Recall Number Z-0648-2013
Classification Class III
Code Info Lots 742 and 743
Product Distributed Qty Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
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) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.

Event Detail

Event Id 63852
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics
City Tarrytown
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-28
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern 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,