Class 2 Device Recall ADVIA TESTpoint Control

• Date Initiated by Firm: June 04, 2025
• Date Posted: July 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2088-2025
• Recall Event ID: 97037
• 510(K)Number: K993825
• Product Classification: Control, cell counter, normal and abnormal - Product Code JCN
• Product: ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
• Code Information: Siemens Material Number 10316217; UDI: 00630414473390, 00630414473390; Lot No. TP252035, TP252045.
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Customer Care Center; 1-800-888-7436
• Manufacturer Reason for Recall: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 3,435 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JCN