Z-2086-2025Class II

ADVIA 120/2120/2120i SETpoint Calibrator

Name: Z-2086-2025 ADVIA 120/2120/2120i SETpoint Calibrator
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-06-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-06-04 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA 120/2120/2120i SETpoint Calibrator on 2025-06-04. FDA classified it as Class II and gives the reason as "Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2086-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-04
Posted: 2025-07-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 120/2120/2120i SETpoint Calibrator
Product code: KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Reason for recall: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
FDA 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 in commerce: 2,020 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.
Product codes and lots: Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2087-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2088-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03
Z-2089-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03

Product code KRZ

K840261Class IICal-Chex, a Hematology CalibratorStreck Laboratories, Inc. / cleared 1984-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)