Recall Z-2480-2015— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2015-07-22, terminated 2015-12-18. It names 2 FDA 510(k) clearances: K061616, K011342. Product: COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.. Reason: Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-22
- Terminated
- 2015-12-18
- 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 Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Reason for recall
Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
Data sourced from openFDA. This site is unofficial and independent of the FDA.