FC 500 Series Flow Cytometers (new, reconditioned or refurbished). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00051-1

Class II

2018-01-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00051-1

As a result of customer complaints and subsequent internal investigations, beckman coulter has determined that an internal electronic component on the circuit “amplifier” boards system may be affected by a manufacturing defect. each fc 500 system contains seven (7) of the potentially affected amplifier boards. all instruments are potentially impacted. there may be impact to patient results due to this issue when using the fc 500 for any application, which may result in failures causing signal loss and/or signal drifting. the failure could present itself as signal loss and/or signal drifting resulting in absence of data or a shift in the population in the data plots.Customers have reported sudden loss of signal, intermittent signal loss, sudden upward or downward shift in signal, upward or downward drift in signal over time, fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation (cv) of flow-check beads.

All Applications including Laboratory Developed Tests, please review all data prior to the release of reported results from the lab and immediately implement the collection of Time as a parameter and create Time versus Parameter plots which will allow the monitoring of signal integrity during data acquisition For tetraCXP and stemCXP it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. Users can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labelling. For ClearLLab Reagents, CytoDiff Application and Laboratory Developed Tests, in addition to the actions above ensure that the appearance of the data patterns are reviewed and look for suboptimal compensation and ensure that the pattern appearance matches the statistical data reported. For CytoDiff Application, in addition to the actions above, compare the results obtained from the cytometer to the results from the hematology analyzer for the same sample, and verify that there is concordance with the results. Contact Beckman Coulter Customer Technical Support Centre or the local Beckman Coulter Representative if any of the issues described occur. Consult with the Medical Director to determine if a retrospective review of results is warranted.