ADVIA 120/2120/2120i SETpoint Calibrator recallZ-2086-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Correction notification dated 6/4/25 was mailed to consignees. This notification provides consignees with calibration instructions given the issue found in affected lots. Additionally, instructions are given on how to proceed with product depending on performance. Consignees are to discontinue use of and discard of the calibrator SETPOINT lots impacted by this recall. Consignee locations are to review the provided notification with their Medical Directors to determine the appropriate course of action. A copy of the recall notification should be retained in laboratory records and shared with users. Consignees are to complete and return the provided Effectiveness Check Form within 30 days of receipt of the recall notification. Consignees with any questions can contact their Siemens Customer Care Center or local Siemens Healthineers technical support representative.
Recall details
- Recall number
- Z-2086-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2025
- Posted by the FDA
- Jul 3, 2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2,020 units
- Product code
- KRZ
- FDA submissions
- K840261
- 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.
Product description
ADVIA 120/2120/2120i SETpoint Calibrator
Code information (models, lots, serial numbers)
Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ADVIA® 120/2120/2120i SETpoint 10312285Siemens Healthcare Diagnostics Inc. · CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97037).
- Z-2087-2025 · Open, ClassifiedADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- Z-2088-2025 · Open, ClassifiedADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
- Z-2089-2025 · Open, ClassifiedADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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