Recalls / —
—#90922
Product
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 product code
- GKZ — Counter, Differential Cell
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K081930
- Affected lot / code info
- All Serial Numbers
Why it was recalled
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.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 200 S Kraemer Blvd, Brea, California 92821-6208
Distribution
- Distribution pattern
- Distributed Nationwide and Canada.
Timeline
- Recall initiated
- 2009-12-08
- Posted by FDA
- 2010-05-26
- Terminated
- 2012-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #90922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.