NEW YORK (360Dx) — Beckman Coulter Life Sciences said on Tuesday that its voluntary recall of its FC500 and EPIC flow cytometry instruments earlier this year has been classified as Class 1 by the US Food and Drug Administration.
In January, the Indianapolis-based Danaher business notified its customers of a potential intermittent or permanent failure of the circuit amplifier boards of its FC500 series flow cytometers, as well as its Coulter EPICS XL and Coulter EPICS XL-MCL flow cytometers with system II software. The issue, Beckman said, could impact all assays run on the cytometers for any application, including laboratory-developed tests.
Any failure, it added, could present itself as an intermittent or sudden signal loss, resulting in absence of data; or as a drift in signal including a sudden upward or downward shift in signal, an upward or downward drift in signal over time, a fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation of Flow-Check beads.
The FDA categorize Class I recalls as ones where there is a reasonable probability that the use of, or exposure to, a recalled product will cause serious adverse health consequences or death.
Beckman said that there have been no known patient injuries related to this issue and that it provided instructions on how to detect the problem to the customers of the 2,549 now-discontinued EPICS units sold globally between 1993 and 2012 and the 3,115 FC 500 units sold globally to date.
Beckman added that it is undertaking a number of additional steps to further address any risks associated with the issue including rolling out software updates to recalled FC 500 units and replacing unit circuit boards in units running the Leukosure white blood cell enumeration application, and issuing a separate notification letter regarding retiring EPICS units.