Siemens ADVIA 120/2120/2120i 3-in-1 TESTpoint Control: Incorrect Platelet Values
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.
Lower-risk recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/52150-siemens-advia-120-2120-2120i-3-in-1-testpoint-control.
Source Summary by GovInfoNow · govinfonow.com/recall/52150-siemens-advia-120-2120-2120i-3-in-1-testpoint-control · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2089-2025
Cite this page
“Siemens ADVIA 120/2120/2120i 3-in-1 TESTpoint Control: Incorrect Platelet Values.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52150-siemens-advia-120-2120-2120i-3-in-1-testpoint-control. Based on FDA recall #Z-2089-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2089-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2086-2025 | ADVIA¿ 120/2120/2120i SETpoint Calibrator; Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043. | 2,020 units |
| Z-2087-2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control); Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045. | 4,214 units |
| Z-2088-2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control); Siemens Material Number 10316217; UDI: 00630414473390, 00630414473390; Lot No. TP252035, TP252045. | 3,435 units |
| Z-2089-2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control); Siemens Material Number 10318905; UDI: 00630414473413, 00630414473413; Lot No. TP253035, TP253045. | 3,266 units |
What to do — step by step
Check Device Details
Verify the Siemens Material Number 10318905 or UDI numbers 00630414473413 to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2089-2025 (June 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2089-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.