Recall Z-2900-2016— Beckman Coulter Inc.

Name: FDA recall Z-2900-2016
Creator: U.S. Food and Drug Administration
Published: 2016-09-06

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-09-06, terminated 2017-08-07. It names one FDA 510(k) clearance: K141932. Product: AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.. Reason: Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-06
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, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

Reason for recall

Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

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