FDAFDA · Food and drugs·Recall number Z-0237-2018
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
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 Number AZ06682
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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