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

FDA device recall Z-0412-2026 · posted 2025-10-30 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

PER

Quantity affected

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

Date initiated

2025-09-08

Date posted

2025-10-30

Location

Miami, FL