Sample preparation systems recalled over a software dispensing error
Beckman Coulter is recalling 50 CellMek SPS Sample Preparation Systems because a software error dispenses samples close to or touching tube bottoms, removing 60-100 microliters from the final sample.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 error may lead to incorrect diagnosis or patient management, and no injuries are reported.
Plain-English summary
The CellMek SPS Sample Preparation System, REF C44603, with software, is being recalled by Beckman Coulter, Inc.
The record states the sample preparation system, designed to automate staining, lysing and cell washing, has a software error that causes samples to be dispensed close to or touching tube bottoms. The record states this could dislodge the fluid line, result in sample loss and spillage, make the instrument inoperable, and will lead to unintentional removal of 60-100 microliters from the final sample, which may lead to incorrect diagnosis or patient management.
The record lists 50 units under UDI-DI 15099590750312, software version 2.3.90.0. Distribution was worldwide, including nationwide in the United States across the states listed in the record and to the countries listed. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- CellMek SPS Sample Preparation System, REF: C44603, with software
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 50
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)
- UDI-DI: 15099590750312. Software Version 2.3.90.0
Distribution
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