Recall Z-1341-2018— Beckman Coulter Inc.

Name: FDA recall Z-1341-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-29

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-01-29, terminated 2019-06-27. It names one FDA 510(k) clearance: K141932. Product: AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.. Reason: The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-29
Terminated: 2019-06-27
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, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

Reason for recall

The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.

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