FDA recall Z-0238-2018

Beckman Coulter Inc. · Class II · device

Product

UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-11-03
Report date
2017-12-20
Termination date
2018-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2018