—#41904

Product

Synchron LX Systems Version 4.5 Operating Software

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K011213, K023049, K965240
Affected 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).

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2005-09-06
Posted by FDA: 2005-10-06
Terminated: 2012-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.