Beckman Coulter Inc COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.
Products Sold
Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.
Beckman Coulter Inc is recalling COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and due to Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, tra. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.
Recommended Action
Per FDA guidance
Customers were notified via U.S. mail by a Product Corrective Action Letter (PCA) dated August 12, 2004. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occurring.
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