Recall Z-3101-2017— Beckman Coulter Inc.

Name: FDA recall Z-3101-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-20

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-06-20, terminated 2021-04-21. It names one FDA 510(k) clearance: K140911. Product: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.. Reason: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-20
Terminated: 2021-04-21
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 Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.

Reason for recall

The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.

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