FDAFDA · Alimentos y medicamentos·N.º oficial Z-0212-2015
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Publicado el 19 de noviembre de 2014 · Inicio del retiro: 20 de octubre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
A typographical error regarding the expiration date was identified in the control module instructions for use.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Healthcare Diagnostics, Inc.
- Distribuidor
- Worldwide Distribution - US Distribution including the states of FL, KY, MN, MA, PA, UT, NY, VA and CA., and the countries of Algeria, Australia, Argentina, Austria, Belgium, Brazil, Bulgaria, Cameron, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Latvia, Macedonia, Mexico, Netherlands,Pakistan, Peru, Poland, Portugal, Rep. Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tadjikistan, Taiwan,Turkey, Unit. Arab Emir and Vietnam.
- Lote
- Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19; PINLCLCM-11{24}, 2014-02-19; PIELCLCM-9{24}, 2014-02-19
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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