Recall Z-0472-2019— Beckman Coulter Inc.
Class I · Terminated
Class I FDA medical device recall by Beckman Coulter Inc., initiated 2018-01-12, terminated 2024-04-30. It names 2 FDA 510(k) clearances: K990172, K963263. Product: COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software. Reason: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-01-12
- Terminated
- 2024-04-30
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K963263 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Reason for recall
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.
Data sourced from openFDA. This site is unofficial and independent of the FDA.