Medical device recalls Moderate risk

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)

Get recall alerts

Free email alert whenever Beckman Coulter Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Beckman Coulter Inc.