RecallRadar

FDA Device recall 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…

On 2017-12-20 the FDA classified a Class II recall of UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is… by Beckman Coulter, citing the shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0237-2018
ClassificationClass II
Statusterminated
Initiated2017-11-03
Published2017-12-20
Last updated2026-09-13 11:54 UTC
CompanyBeckman Coulter
DistributionAR, CA, HI, MD, OH, WA

Product

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)

Reason

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

Identifiers

code_infoSerial Number AZ06682

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0237-2018%22

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