Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

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.

• FDA enforcement recordOfficial FDA database entry for Z-2089-2025
• FDA 510(k) clearance · K993825The device's official FDA premarket clearance record
• FDA device classification · JCNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.8625The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.