Sample preparation systems recalled over incorrect dead volumes in instructions
Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the defect may lead to incorrect diagnosis or an error in patient management, and no injuries are reported.
Plain-English summary
The Beckman Coulter CellMek SPS Sample Preparation System, REF C44603, running software version 2.2.122.0 and prior with Instructions for Use revisions AD and prior, is being recalled. The affected devices include Cassette E.
The instructions for use list incorrect dead volumes: for Cassette Type B the listed volume is 750 microlitres against a correct volume of 1,582 microlitres, and for Cassette Type E the listed volume is 1,300 microlitres against a correct volume of 2,093 microlitres. In addition, the device software does not rock Cassette E when used with 15mm x 92mm Sarstedt tubes. The firm states this may lead to incorrect diagnosis or error in patient management and treatment.
The recall covers 108 units across all serial numbers between BE43003 and BJ18014, manufactured from 3 December 2021 to 15 April 2025, distributed worldwide including in Alabama, Arkansas, Florida, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, New York, Oregon, Tennessee and Utah. The FDA has classified the action as Class II.
Laboratories operating an affected system should follow Beckman Coulter's instructions.
The recalled product
- 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.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers between BE43003 through BJ18014
Distribution
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