Device 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.
Z-2480-2015
Product summary
- Event
- Event 71835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 409,042 units (339,545 units in US)
- Official record key
device-enforcement:Z-2480-2015
Official wording
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.
Code information: Lot Numbers: 510376F-510657F, M405229-M503553.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.