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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2428-2024

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Publicado el 31 de julio de 2024 · Inicio del retiro: 27 de mayo de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Beckman Coulter Inc.
Distribuidor
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China (DX), Colombia, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Province of China, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam, Yemen.
Lote
UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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