COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer)
Recall
- Recall Number
- Z-0314-2008
- Event Number
- 44916
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 18, 2007
- Posted
- December 22, 2007
- Terminated
- April 16, 2012
- Address
- 200 S Kraemer Blvd, Brea, CA, 92822-6208
Description
COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer)
Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th
Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.
World wide: USA and Canada
917 units in the US; 82 units to Canada