device · product 1 of 2
Atellica IM Erythropoietin (EPO) Assay (100 Test)
- Recall number
- Z-1280-2024
- Initiated
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1,057 units (46 US, 1,011 OUS)
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
Siemens Material Number: 10733006; UDI/DI: 00630414245775; Kit Lots: 53982039, 55439041.
Distribution pattern
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.