Siemens Healthcare recalls Atellica IM anti-CCP IgG (aCCP) Assay (Material #10732998) due to mitigation failure in TDef Version 1.0. This affects test accuracy for rheumatoid arthritis diagnosis.
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure
Siemens Healthcare is recalling Atellica IM anti-CCP IgG (aCCP) Assay (Material #10732998) because a software issue in version 1.0 can cause test results to be inaccurate. This affects rheumatoid arthritis diagnosis and requires correction to ensure accurate results.
The test software version 1.0 has a mitigation failure that prevents proper completion of the test. This means results may be inaccurate, potentially affecting rheumatoid arthritis diagnosis. The issue is isolated to the specific software version and does not cause physical harm.
Patients using the Atellica IM anti-CCP IgG (aCCP) Assay for rheumatoid arthritis testing. Laboratory users who perform this test are most at risk of inaccurate results.
Check for the Siemens Material Number 10732998 (100 Test) with Test Version 1.0. This assay is used for rheumatoid arthritis testing and was sold through the Replacement Reagent Policy.
Verify the test version is 1.0 on the Atellica IM anti-CCP IgG (aCCP) Assay (Material #10732998).
Reach out to Siemens Healthcare for guidance on updating the software or replacing the test.
The test software version 1.0 has a mitigation failure that can cause inaccurate results for rheumatoid arthritis diagnosis.
No, this is a software issue that affects test accuracy but does not cause physical harm.
Check for the Siemens Material Number 10732998 (100 Test) with Test Version 1.0.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2754-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2754-2019 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
