Z-0412-2026Class II

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions...

Name: Z-0412-2026 CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions...
Creator: Beckman Coulter, Inc.
Published: 2025-09-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-09-08 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek... on 2025-09-08. FDA classified it as Class II and gives the reason as "Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters...". 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-0412-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-08
Posted: 2025-10-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Reason for recall: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter notified consignees via email and letter on about 09/08/2025. For Issue 1 (Incorrect Dead Volumes), consignees were instructed to use the actual specimen dead volumes stated in Issue Description in the notification letter when processing samples in CellMek SPS with Sarstedt brand tubes. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter also recommends posting this letter on or near the affected instruments. Beckman Coulter will provide the correct CellMek SPS specimen dead volumes for Sarstedt brand tubes (Cassette Types B and E) in the next revision of the CellMek SPS Instructions for Use For Issue 2 (), consignees were instructed not to use Cassette Type E (15mm X 92mm Sarstedt brand tubes) to process samples on CellMek SPS. Beckman Coulter recommends sharing the content of the notification letter with laboratory and/or medical director regarding the need to review previous patient test results that were generated using the Sarstedt brand tubes. Beckman Coulter recommends posting the notification letter on or near the affected instruments. Beckman Coulter is actively investigating this issue and plans to address it in a future product release. Additionally, customers were instructed to notify personnel/customers if any affected units were transferred/distributed to another laboratory, and to complete and return the response form.
Quantity in commerce: 108 units
Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: All serial numbers between BE43003 through BJ18014, manufactured from 12/03/2021 to 04/15/2025. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0412-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-30

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)