FDA-Device2015-09-09Class II
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.
Beckman Coulter Inc.
Hazard
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.
Sold states
Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.
Affected count
409,042 units (339,545 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2015Don't want to check this manually?
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