Recall Z-2035-2017— Beckman Coulter Inc.

Name: FDA recall Z-2035-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-03

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-03, terminated 2017-08-07. It names one FDA 510(k) clearance: K141932. Product: AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).. Reason: Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Terminated: 2017-08-07
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOSBeckman Coulter, Inc.·cleared 2015-04-10

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

AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).

Reason for recall

Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.

Data sourced from openFDA. This site is unofficial and independent of the FDA.