Beckman Coulter PrepPlus 2 Recalled for Sample Preparation Imprecision
Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
What this means for you
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, and the hazard involves imprecision in diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Beckman Coulter Inc. is recalling 473 units of the Coulter PrepPlus 2 (Part Number 378600) sample preparation system. The device is a microprocessor-controlled pipetting and diluting system used in combination with the COULTER TQPrep Workstation to prepare human whole blood for In Vitro Diagnostic (IVD) use on cleared Beckman Coulter flow cytometers.
The recall was initiated because samples prepared using the PrepPlus 2 system may exhibit imprecision in the absolute counts on only the first tube in a run. This issue affects the accuracy of the initial sample in a sequence when run on a flow cytometer.
The affected units were distributed worldwide. The recall covers all serial numbers currently in the field. Users of the device should contact Beckman Coulter Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Be
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 473
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- High
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · imprecise results
See all →- ModerateRandox Lipase Assay Buffer Recalled for Imprecision in Quality Control
FDA (Devices) · 2020-08-12
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
FDA (Devices) · 2018-07-11
- HighSiemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision
FDA (Devices) · 2013-11-13
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems
FDA (Devices) · 2013-04-24
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
FDA (Devices) · 2013-04-24