FDA recall Z-0237-2018

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 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-0237-2018