SYNCHRON LX20 AND LX20 Pro
FDA Recall Z-0545-03 · Posted 2003-02-05
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJGS
Date Initiated2002-12-16
Date Terminated2004-12-01
Product Quantity1001
Reason for Recall
The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
Firm Action
Firm will inspect instruments for failure conditions and fix the problem.
Root Cause
Other
Distribution Pattern
Canada and USA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc. · 2001-12-18K011213MODIFICATION 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.