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Recall Observatory FDA recall evidence

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

July 22, 2015

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.no_named_rule · v1.0.0

    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.