PrepPlus 2 378600Recalls & reported problems
Beckman Coulter, Inc. · COULTER PrepPlus 2 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590638191), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K130253); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED COMPENSATION CONCERNS ON SAMPLES RUN ON THEIR NAVIOS FLOW CYTOMETRY INSTRUMENT PART NUMBER B47905, SERIAL NUMBER (B)(4). IT IS UNKNOWN HOW MANY PATIENTS WERE IMPACTED. THE INFORMATION AND DATA WAS REQUESTED FROM THE CUSTOMER BUT THEY WERE NOT ABLE TO PROVIDE SPECIFIC INFORMATION OR DATA. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11453238 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130253. One submission often covers many models, so check the product and lot details in each record.
- Z-2690-2017 · May 22, 2017 · TerminatedCoulter 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 bl
- Z-2689-2017 · May 22, 2017 · TerminatedCoulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation
Other Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis devices
- FACS 647205Becton, Dickinson And Company · Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis123 reports
- Sample Preparation System PS-10Sysmex Corporation · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 recall3 reports
- BD FACSDuet 666340Becton, Dickinson And Company · Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis1 recall1 report
- BD FACSDuet 663128Becton, Dickinson And Company · Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis1 recall1 report
- Cellmek C44603Beckman Coulter, Inc. · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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