Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)
This recall has been terminated (originally issued March 6, 2007).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- September 12, 2006
- Posted
- March 6, 2007
- Terminated
- April 19, 2012
- Recall Number
- Z-0566-2007
- Quantity
- 1893 units in the US; 94 units to Canada
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
Distribution
Nationwide and Canada
Lot / Code Info
Part Number 6605632, with 2B Software (2B3, 2B4 and 2B5)
Root Cause
Other
Action Taken
A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.