UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, autom
FDA device recall Z-1656-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 63 units
- Distribution
- 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.
- Date initiated
- 2010-03-02
- Date posted
- 2010-05-26
- Date terminated
- 2012-05-23
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |