FDAFDA · Food and drugs·Recall number Z-1280-2024
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Published March 20, 2024 · Recall initiated: January 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, U.A.E., United Kingdom.
- Lot
- Siemens Material Number: 10733006; UDI/DI: 00630414245775; Kit Lots: 53982039, 55439041.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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