Siemens Recalls Atellica IM Anti-CCP IgG Assay Due to Mitigation Failure
Siemens Healthcare Diagnostics is recalling 169 kits of the Atellica IM anti-CCP IgG assay because a reagent carryover mitigation step fails to complete on the analyzer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a technical failure in the analyzer's mitigation process, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 169 kits of the Atellica IM anti-CCP IgG (aCCP) Assay, Siemens Material Number 10732998 (100 Test), Test Version 1.0. The recall affects all lots of this specific test version.
The recall is due to a Test Definition (TDef) mitigation failure. Specifically, the reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition. This issue occurs on the Atellica IM Analyzer and is isolated to TDef Version 1.0. For Outside U.S. (OUS) markets, the issue also affects the Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition mitigation.
The product was distributed worldwide, including nationwide in the United States and in specific states such as CA, FL, KY, NH, and TX, as well as in countries including Austria, Curacao, Czech Republic, Denmark, France, Germany, Greece, Italy, Poland, Slovakia, Spain, Switzerland, and the U.A.E. The assay is used for in vitro diagnostic purposes to aid in the diagnosis of rheumatoid arthritis. Users should contact Siemens Healthcare Diagnostics for further instructions on handling the affected kits.
The recalled product
- Product
- Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 169
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 (1)
- All lots
Distribution
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