Recall Z-0471-2019

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

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 Applications including Laboratory Developed Tests: a. As per the product documentation all data must be reviewed by a laboratory professional prior to the release of reported results from the lab. b. 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 as instructed in Attachment 2. c. Review data as described below: i. Review of all Time plots for each parameter. ii. Monitor consistent Forward Scatter, Side Scatter and all fluorescence data over time as shown in Attachment 2. iii. Unexpected fluctuations in the events over time may indicate compromised fluidics, signal integrity or data acquisition conditions. iv. All data must be reviewed prior to the release of any results from the laboratory, via an LIS or any other mechanism. 2. For tetraCXP and stemCXP: a. As it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. b. You can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labeling. Refer to CYTO-STAT tetraCHROME IFU, PN B90108 (for tetraCHROME CD45- FITC/CD4-RD1/CD8-ECD/CD3-PC5, PN 6607013 and tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, PN 6607073) and the Stem-Kit IFU, PN B6