FDA-Device2017-12-20Class II
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)
Beckman Coulter Inc.
Hazard
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Sold states
CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Affected count
1 unit
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief