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-1656-2010 · Posted 2010-05-26
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-03-02
Date Terminated2012-05-23
Product Quantity63 units
Reason for Recall
Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results.
Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files.
Impact: If the last run for a control lot
Firm Action
Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form.
For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution (AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, WA, and WI) and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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