Recall Z-2732-2016— Beckman Coulter Inc.

Name: FDA recall Z-2732-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-08-08, terminated 2017-04-29. It names one FDA 510(k) clearance: K140911. Product: UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).. Reason: There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2017-04-29
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 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).

Reason for recall

There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.

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