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Immunoradiometric assay.

FDA Recall #Z-0647-2013 — Class III — November 28, 2012

Recall #Z-0647-2013 Date: November 28, 2012 Classification: Class III Status: Terminated

Product Description

Immunoradiometric assay.

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 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)

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 831 and 832

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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