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Terminated

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)

FDA Recall Z-0237-2018 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2017-11-03
Date Terminated2018-06-19
Product Quantity1 unit

Reason for Recall

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

Firm Action

The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."

Root Cause

Device Design

Distribution Pattern

CA, AR, HI, CA, OH, WA, MD, Canada, Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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