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Recall Observatory FDA recall evidence

Device product

COULTER ISOTON 4 Diluent, Catalog No. 8547148. 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-2481-2015

July 22, 2015

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 71835
Status
Terminated
Classification
Class II
Quantity
710 units
Official record key
device-enforcement:Z-2481-2015

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: 18203F-18206F.

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.