ClearanceBrief
Recall Z-0091-2018 ยท OYE Flow Cytometric Reagents And Accessories.

Beckman Coulter Inc.

AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reag

DateOct 2, 2017
StatusTerminated
ReasonThe system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
Root causeSoftware design
ActionBeckman Coulter sent an Urgent Medical Device Recall letter dated September 28, 2017, and via phone on October 4, 2017. On 11/30/2017, the firm issued an updated letter dated 11/28/2017. The letter informs the customer this letter replaces the instructions in the original notification dated 9/28/2017.
Quantity268 units
DistributionWorldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, F
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K141932AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
Beckman Coulter, Inc., Apr 10, 2015