RecallRadar

FDA Device recall Z-0236-2018

UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer

On 2017-12-20 the FDA classified a Class II recall of UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer 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-0236-2018
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 DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer

Reason

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

Identifiers

code_info
Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, A…Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151

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-0236-2018%22

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