Siemens Healthcare recalls ADVIA 120/2120/2120i SETpoint Calibrators with incorrect platelet value assignments. Affected units have specific Siemens material numbers and lot numbers.
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Siemens Healthcare is recalling ADVIA 120/2120/2120i SETpoint Calibrators because they have incorrect platelet (PLT) value assignments for hematology systems. This could lead to inaccurate blood test results if the calibrator is used without correction.
The calibrators have incorrect platelet value assignments, which can cause blood test results to be inaccurate. This may lead to misdiagnosis or incorrect treatment decisions if the calibrator is used without correction.
Users of the ADVIA 120/2120/2120i hematology systems who have the recalled calibrators. Laboratory technicians and healthcare providers using these systems are most at risk of inaccurate test results.
Check for the Siemens Material Number 10312285 and lot numbers SP251033 or SP251043 on the calibrator. The recall applies to ADVIA 120/2120/2120i SETpoint Calibrators sold with specific UDI codes.
Verify the Siemens Material Number 10312285 and lot numbers SP251033 or SP251043 on the calibrator.
The calibrator has incorrect platelet value assignments for the ADVIA 120/2120/2120i hematology systems, which could lead to inaccurate blood test results.
Check the calibrator for the Siemens Material Number 10312285 and lot numbers SP251033 or SP251043. If it matches, contact Siemens Healthcare for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2086-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2086-2025 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.
