COULTER LH 750 Hematology Analyzer.
This recall has been terminated (originally issued February 10, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- December 16, 2004
- Posted
- February 10, 2005
- Terminated
- April 26, 2012
- Recall Number
- Z-0536-05
- Quantity
- 1,257
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.
Distribution
US and Canada
Lot / Code Info
Part Number 6605632
Root Cause
Other
Action Taken
Letter 12/20/04 A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation''s database are not affected. If the LH750 instrument displays a pop-up winder titled Database Error (XXXXXX) and text similar to (Microsoft) (ODBC SQL...) As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Do not acknowledge the error. Instead, restart the entire system by completely powering it OFF and then ON. Or, if the LH750 Workstation experiences a change in performance, such as screen display freezes, slow response time, or requires frequent resets to continue processing. As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Verify the accuracy of all patient reports for the samples until service confirms the performance of system.