ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Siemens Material Number 10330063, UDI: 00630414473406, 00630414473406, Lot No. TP251035, TP251045.
Products Sold
Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) due to Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026