Z-1235-2026Class II

CellMek SPS Sample Preparation System, REF: C44603, with software

Name: Z-1235-2026 CellMek SPS Sample Preparation System, REF: C44603, with software
Creator: Beckman Coulter, Inc.
Published: 2025-12-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-12-23 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of CellMek SPS Sample Preparation System, REF: C44603, with software on 2025-12-23. FDA classified it as Class II and gives the reason as "Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1235-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-23
Posted: 2026-02-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CellMek SPS Sample Preparation System, REF: C44603, with software
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Reason for recall: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
Root cause tag: software
FDA root cause: Software change control
Action: On 12/23/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) To mitigate the risk of contact between the dispense probe and the tube bottom, utilize CellMek SPS output tubes distributed by Beckman Coulter. 2) For absolute count assays, use the CellMek SPS on-board counting bead feature. Do not add counting beads to samples manually after preparation with CellMek SPS. 3) Share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 4) Firm recommends posting this letter on or near the affected instruments. 5) Complete and return the response form. Firm will perform an on-site service modification to update your instrument software to correct this issue. If you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckman.com, (800) 369-0333
Quantity in commerce: 50
Distribution: Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.
Product codes and lots: UDI-DI: 15099590750312. Software Version 2.3.90.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02

Product code PER

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)