Recall Z-0113-2014— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-09-24, terminated 2014-10-09. It names 2 FDA 510(k) clearances: K061616, K011342. Product: COULTER LH 750 and LH 780 Analyzers. 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. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also 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: The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-24
- Terminated
- 2014-10-09
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K061616 — COULTER LH 780 HEMATOLOGY ANALYZER
- K011342 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
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 and LH 780 Analyzers. 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. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also 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
The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.
Data sourced from openFDA. This site is unofficial and independent of the FDA.