ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Summary
The FDA issued a Class II for ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) by Siemens Healthcare Diagnostics, Inc.. Reason: Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standa.
Details
Source
Device Recall
External ID
Z-1281-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Lot/Code Info: Siemens Material Number: 10995096; UDI/DI: 00630414010380; Kit Lots: 53984040, 55443042.
Quantity Affected: 264 units (6 US, 258 OUS)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-24
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1281-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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