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.
This recall has been terminated (originally issued September 2, 2004).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- August 12, 2004
- Posted
- September 2, 2004
- Terminated
- April 26, 2012
- Recall Number
- Z-1433-04
- Quantity
- 222
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide & Canada
Lot / Code Info
Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.
Root Cause
Other
Action Taken
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.
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