| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00051-1 |
| Product Name/Description |
FC 500 Series Flow Cytometers (new, reconditioned or refurbished). An in vitro diagnostic medical device (IVD)
All Part Numbers
All Software Versions
ARTG Number: 177999 (Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
For all Applications including Lab Developed Tests, review all data prior to the release of reported results from the lab. Immediately implement collection of Time as a parameter & create Time vs Parameter plots.
tetraCXP & stemCXP it is not possible to add time versus parameter. Discontinue use of the automated applications. Users can continue to use the tetraCHROME & Stem Kit reagents with the manual gating instructions.
ClearLLab reagents, CytoDiff & Lab Developed Tests, incl. the above actions, ensure that the appearance of the data patterns are reviewed. Look for suboptimal compensation & ensure that the pattern appearance matches the statistical data.
CytoDiff Applications, incl, the above actions, compare results from the cytometer to the haematology analyser for the same sample, verify concordance with the results.
Contact Beckman Coulter if any of the issues occur. Consult with the Medical Director to determine if a retrospective review of results is warranted.
This action has been closed out on 13/09/2019 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |