FDA-Device2025-11-05Class IIPROCESSING DEFECT
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.
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
108 units
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2026Want us to check the next one for you?
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