Recall Z-0412-2026— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-09-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-08
- Firm location
- Miami, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.