Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
This recall has been terminated (originally issued July 18, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- April 17, 2006
- Posted
- July 18, 2006
- Terminated
- April 19, 2012
- Recall Number
- Z-1245-06
- Quantity
- 759
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
Distribution
Nationwide and Canada
Lot / Code Info
All software versions.
Root Cause
Other
Action Taken
A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.
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