Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

FDA Recall Z-1680-2010 · Posted 2010-05-26

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2009-12-08
Date Terminated2012-06-04
Product Quantity42 units (40 in US)

Reason for Recall

The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.

Firm Action

Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated December 8, 2009. Consignees were informed of the affected product and provided temporary solutions until further support will be made available. For additional information, contact your local Beckman Coulter Representative or call 800-526-7694.

Root Cause

Software design

Distribution Pattern

Distributed Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081930UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc. · 2008-12-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑