Atellica IM Erythropoietin (EPO) Assay (100 Test)
Reported: March 20, 2024 Initiated: January 24, 2024 #Z-1280-2024
Product Description
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1,057 units (46 US, 1,011 OUS)
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica IM Erythropoietin (EPO) Assay (100 Test). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1,057 units (46 US, 1,011 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1280-2024.
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