Beckman Coulter, Inc. is recalling 108 units of the CellMek SPS Sample Preparation System because the instructions for use contain incorrect measurements for certain cassettes. Additionally, the system software fails to properly mix (rock) specific tubes used in 'Cassette E' configurations. These technical errors can result in the device using incorrect fluid volumes during sample preparation, which may lead to inaccurate laboratory test results and incorrect patient diagnoses.
Incorrect fluid measurements and poor sample mixing can cause errors in flow cytometric analysis. If a laboratory provides inaccurate results due to these defects, a healthcare provider might make incorrect decisions regarding a patient's management or medical treatment.
Manufacturer correction or return
Includes Cassette E and Cassette B. Associated with 15mmX92mm Sarstedt tubes.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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