Beckman Coulter PrepPlus Recalled for Imprecise Sample Preparation
Beckman Coulter is recalling 43 PrepPlus systems because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a precision defect in data output without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm is not explicitly reported.
Plain-English summary
Beckman Coulter Inc. is recalling 43 units of the Coulter PrepPlus, Part Number 286600. This microprocessor-controlled pipetting and diluting system is designed for automating sample preparation or assay methods. The recall covers all serial numbers currently in the field, with distribution reported as worldwide.
The recall is due to a defect where samples prepared using the PrepPlus or PrepPlus 2 systems and subsequently run on a flow cytometer exhibit imprecision in the absolute counts on only the first tube in a run. This issue may affect the accuracy of the initial sample in a sequence.
Users of the affected devices should contact Beckman Coulter Inc. for further instructions regarding the recall and potential remediation.
The recalled product
- Product
- Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 43
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 currently in the field
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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