FDA Device

Synchron LX Systems Version 4.5 Operating Software

Hazard

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.

What You Should Do

Remedy

Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.

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Products

Synchron LX Systems Version 4.5 Operating Software
Brand
Beckman Coulter Inc
UPC
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).

Units Affected

868

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