Siemens Healthcare recalls ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) due to incorrect platelet value assignments. Affected units have specific 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 3-in-1 TESTpoint Control (Norm Control) products because they have incorrect platelet (PLT) value assignments. This could lead to inaccurate blood test results if used without correction.
The recalled testpoints have incorrect platelet value assignments, which could cause inaccurate blood test results. This might lead to misdiagnosis or incorrect treatment decisions if the test is not corrected.
Patients using blood tests with these specific ADVIA 120/2120/2120i systems may be affected. Laboratory staff and healthcare providers using the recalled testpoints are most at risk.
Check for Siemens Material Number 10316217 or UDI numbers 00630414473390. Lot numbers TP252035 and TP252045 indicate affected units.
Verify the Siemens Material Number 10316217 and UDI numbers 00630414473390 to confirm if your unit is affected.
The testpoints have incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Check for Siemens Material Number 10316217 or UDI numbers 00630414473390 with lot numbers TP252035 or TP252045.
The recall does not require immediate stop use; affected units should be checked for correct assignments.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2088-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2088-2025 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.
