Siemens Healthcare recalls ADVIA 120/2120/2120i 3-in-1 TESTpoint Control units with incorrect platelet value assignments. Affected units may provide inaccurate blood test results.
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 devices due to incorrect platelet (PLT) value assignments. This could lead to inaccurate blood test results, potentially affecting diagnosis and treatment decisions.
The device assigns the wrong platelet values in blood tests, which could result in inaccurate test results. This might lead to incorrect medical decisions if the test results are used for diagnosis or treatment.
Users of the ADVIA 120/2120/2120i hematology systems who have the specific TESTpoint Control units with incorrect platelet assignments. Laboratory staff and healthcare providers using these devices are most at risk.
Check for the Siemens Material Number 10318905 or the unique device identifier (UDI) numbers 00630414473413. The lot numbers TP253035 and TP253045 also indicate affected units.
Verify the Siemens Material Number 10318905 or UDI numbers 00630414473413 to confirm if your device is affected.
The device has incorrect platelet value assignments, which could lead to inaccurate blood test results.
Check for the Siemens Material Number 10318905 or UDI numbers 00630414473413. Affected units also have lot numbers TP253035 or TP253045.
The recall does not specify a remedy, so contact Siemens Healthcare directly 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-2089-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2089-2025 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.
