Recall Z-0237-2018— Beckman Coulter Inc.

Name: FDA recall Z-0237-2018
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 DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities). 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 DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)

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.