ClearanceBrief
Recall Z-0545-03 ยท JGS Electrode, Ion Specific, Sodium

Beckman Coulter Inc

SYNCHRON LX20 AND LX20 Pro

DateFeb 5, 2003 (initiated Dec 16, 2002)
StatusTerminated
ReasonThe disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
Root causeOther
ActionFirm will inspect instruments for failure conditions and fix the problem.
Quantity1001
DistributionCanada and USA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011213MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
Beckman Coulter, Inc., May 16, 2001
K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
Beckman Coulter, Inc., Dec 18, 2001
K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
Beckman Instruments, Inc., Mar 10, 1997