Beckman Coulter Inc Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All software versions.
Products Sold
All software versions.
Beckman Coulter Inc is recalling Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834 due to Beckman has confirmed that erroneous results could be reported when the workstation database crashes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026