Recall Z-0471-2019— Beckman Coulter Inc.
Class I · Terminated
Class I FDA medical device recall by Beckman Coulter Inc., initiated 2018-01-12, terminated 2024-04-30. It names 2 FDA 510(k) clearances: K071681, K030828. Product: 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics. 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..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-01-12
- Terminated
- 2024-04-30
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K071681 — CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
- K030828 — TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.