Synchron LX Systems Version 4.5 Operating Software
FDA Recall Z-0009-06 · Posted 2005-10-06
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2005-09-06
Date Terminated2012-01-26
Product Quantity868
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.
Firm Action
Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
Root Cause
Software design
Distribution Pattern
Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K023049SYNCHRON LX I 725 CLINICAL SYSTEMBeckman Coulter, Inc. · 2002-10-04K011213MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEMBeckman Coulter, Inc. · 2001-05-16K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LBeckman Instruments, Inc. · 1997-03-10
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.