Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures
Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.
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. The hazard involves a functional failure that could lead to incorrect sample preparation, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the COULTER PrepPlus, a microprocessor-controlled pipetting and diluting system, due to confirmed intermittent reagent level sense failures. The instrument may fail to produce a warning when a reagent vial is low or out of reagent.
The recall affects 36 units total, with 15 units distributed in the United States. The product was distributed worldwide, including in Australia, Botswana, Canada, France, Germany, Japan, Malawi, and Sweden. All serial numbers are included in this recall.
Users should stop using the device and contact Beckman Coulter for instructions on how to proceed.
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.
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
Distribution
Distributed nationwide across the United States.
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