FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- Recall number
- Z-2087-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- Status
- Open, Classified
- Initiated
- 2025-06-04
- Posted
- 2025-07-03
- Terminated
- not on file
- Reason
- Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Root 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
- 4,214 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.
- Lot, serial or model codes
- Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
- 510(k) numbers
- ["K993825"]
- PMA numbers
- not on file
- Product code
- JCN
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28