Recall Z-0470-2014— Beckman Coulter Inc.

Name: FDA recall Z-0470-2014
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: K011342. Product: Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Reason: Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes..

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

K011342 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632Beckman Coulter, Inc.·cleared 2001-07-09

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

Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids

Reason for recall

Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.

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