Recalls / —

—#214304

Product

ADVIA 120/2120/2120i SETpoint Calibrator

FDA product code

KRZ — Calibrator For Hemoglobin And Hematocrit Measurement

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K840261

Affected lot / code info

Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-06-04

Posted by FDA

2025-07-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.