Recall Z-1829-2014— Beckman Coulter Inc.

Name: FDA recall Z-1829-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-08

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-11-08, terminated 2014-12-25. It names one FDA 510(k) clearance: K081930. Product: UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.. Reason: Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Terminated: 2014-12-25
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081930 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc.·cleared 2008-12-19

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 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Reason for recall

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

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