ADVIA Centaur Erythropoietin Assay Affected by -35% Measurement Bias
Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II FDA recall involves a functional diagnostic accuracy issue with a significant -35% measurement bias. While no illnesses or injuries are reported, the risk of harm is concrete: incorrect EPO readings could lead to inappropriate clinical treatment decisions. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) due to a consistent negative measurement bias. The affected assay lots produce results approximately 35% lower than the WHO International Standard (NIBSC code: 11/170), with this bias proportional across the entire measuring interval.
Affected lots 53984040 and 55443042 do not achieve the reference interval specified in the Instructions for Use (IFU). This diagnostic inaccuracy means patients tested with the affected assay may receive falsely low EPO readings, which could lead to inappropriate clinical decisions regarding treatment for anemia and related conditions.
The recall affects 264 units: 6 units distributed in the United States (Alabama, California, Iowa, Illinois, Michigan, Minnesota, North Carolina, Nebraska, Nevada, New York, Ohio, and Texas) and 258 units distributed internationally in Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, China, Pakistan, Poland, Portugal, South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and the United Kingdom.
Healthcare providers should stop using affected lots and retest patient samples with alternative methods. Previous results obtained with the affected assay lots should be reviewed, as those readings may be unreliably low.
The recalled product
- Product
- ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Siemens Material Number: 10995096
- UDI/DI: 00630414010380
- Kit Lots: 53984040
- 55443042.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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