Recall Z-3135-2017— Beckman Coulter Inc.

Name: FDA recall Z-3135-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-21

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-08-21, terminated 2023-09-27. It names one FDA 510(k) clearance: K141932. Product: AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.. Reason: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-21
Terminated: 2023-09-27
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 System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

Reason for recall

Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.

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