Synchron LX Systems Version 4.5 Operating Software
This recall has been terminated (originally issued October 6, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- September 6, 2005
- Posted
- October 6, 2005
- Terminated
- January 26, 2012
- Recall Number
- Z-0009-06
- Quantity
- 868
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
Distribution
Nationwide and Canada
Lot / Code Info
Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database).
Root Cause
Software design
Action Taken
Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.