Beckman Coulter Inc. recalls UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 8…
- Recall date
- November 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0237-2018
- FDA classification
- Class II
- Brand / firm
- Beckman Coulter Inc.
- Sold / distributed
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Why it was recalled
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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)
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