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Recall Observatory FDA recall evidence

Device product

UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

Z-0238-2018

November 03, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 78611
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0238-2018

Official wording

Reason: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

Code information: Serial Numbers: AW09034, AV40142, AU19113

Distribution pattern: CA, AR, HI, CA, OH, WA, MD, Canada, Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.