Beckman Coulter Inc Synchron LX Systems Version 4.5 Operating Software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron LX Systems Version 4.5 Operating Software
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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).
Beckman Coulter Inc is recalling Synchron LX Systems Version 4.5 Operating Software due to Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026