Recall Z-0238-2018— Beckman Coulter Inc.

Name: FDA recall Z-0238-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-03

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-11-03, terminated 2018-06-19. It names one FDA 510(k) clearance: K140911. Product: UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer. Reason: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Terminated: 2018-06-19
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc.·cleared 2014-09-05

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

UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

Reason for recall

The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

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