Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect
Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Beckman Coulter Inc. is recalling 2,549 units of COULTER EPICS XL, COULTER EPICS XL-MCL, and SYSTEM II Software flow cytometers. The recall covers units distributed worldwide, including the United States and Puerto Rico, as well as numerous countries across Asia, Europe, Africa, and the Americas.
The recall is due to a manufacturing defect on the amplifier board that may cause signal loss and/or signal drifting. This defect can result in the absence of data or a population shift in data plots, which can impact patient results for any application.
The affected products were manufactured between specific dates: FC-500 units from January 22, 2002, to January 31, 2018, and EPICS XL/XL-MCL units from November 1, 1992, to March 15, 2013. Users should contact Beckman Coulter for further instructions on how to address this defect.
The recalled product
- Product
- COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,549
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 (3)
- XL Flow Cytometer 100-240V
- XL/MCL Flow Cytometer 100-240V
- MCL
Distribution
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.
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