Recall Z-0472-2019 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
| Date | Nov 20, 2018 (initiated Jan 12, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 01/12/2018 the firm sent an Urgent Medical Device Recall Letter to affected customers via email/mail informing them that as a result of customer complaints and subsequent internal investigations, Beckman Coulter has determined that an internal electronic component on the circuit Amplifier boards in the FC 500 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. Customers were informed to implement the following actions for the application used: 1. For All Application |
| Quantity | 2549 |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963263 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 Coulter Corp., Jan 22, 1997 |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA Coulter Corp., Apr 13, 1999 |