FDA Device recall Z-0472-2019
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
- FDA Device
- Class I
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class I recall of COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software by Beckman Coulter, citing 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 plo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0472-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-01-12 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
Identifiers
| code_info | EPICS Catalog Number: EPICS CL 3 CO…EPICS Catalog Number: EPICS CL 3 COLOR W/MCL 220V 6604985 XL 4CLR FLOW CENTRE 220V AC 6605465 PKG; 4 COLOR XL M/M (220V) 6605465R XL-MCL 4 CLR FLOW CENTRE 220V A 6605437 XL-MCL 4 CLR FLOW CENTRE 240V AC 6605438 XL-MCL 4 CLR FLOW CENTRE 220V A 6605437R EPICS XL 4 COLORS 115V 6604714 XL-MCL 4CLR FLOW CENTRE 100VAC 6605435 TN, XL Flow Cytometer 100-240V, 50/60Hz 626551 EPICS XL 3 COLOR 230V 6604726 EPICS XL 4 CLR/ MCL 115V 6604988 EPICS XL 4 CLR/ MCL 220V |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0472-2019%22
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