PlainRecalls
FDA Devices Moderate Class II 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)

Reported: December 20, 2017 Initiated: November 3, 2017 #Z-0237-2018

Product Description

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
1 unit
Distribution
CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Location
Brea, CA

Frequently Asked Questions

What product was recalled?
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). Recalled by Beckman Coulter Inc.. Units affected: 1 unit.
Why was this product recalled?
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2017. Severity: Moderate. Recall number: Z-0237-2018.