ADVIA Centaur Erythropoietin recall
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Why was ADVIA Centaur Erythropoietin 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number: 10995096; UDI/DI: 00630414010380; Kit Lots: 53984040, 55443042.
- Product
- ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 264 units (6 US, 258 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.
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)