Company: Beckman Coulter, Inc., .
Date of Enforcement Report: 9/6/2005
Class:I
PRODUCT
Synchron LX Systems Version 4.5 Operating Software, Recall # Z-0009-06
REASON
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.
CODE
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)
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter dated September 6, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
868 units
DISTRIBUTION
Nationwide and Canada
