FDAFDA · Food and drugs·Recall number Z-0236-2018
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Published December 20, 2017 · Recall initiated: November 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
- Lot
- Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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