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U.S. Department of Health and Human Services

Class 2 Device Recall CellMek SPS Sample Preparation System

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 Class 2 Device Recall CellMek SPS Sample Preparation Systemsee related information
Date Initiated by FirmSeptember 08, 2025
Date PostedOctober 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0412-2026
Recall Event ID 97531
Product Classification Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
ProductCellMek 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.
Code Information 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.
FEI Number 3000203293
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information ContactKristin Godfredsen
760-419-7078
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionBeckman 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 Commerce108 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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