Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0412-2026 — 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.

U.S. FDA — Device Enforcement · United States · 2025-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0412-2026
Date of alert: 2025-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0412-2026 — 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.

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