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Terminated

Synchron LX Clinical Systems Software

FDA Recall Z-1116-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2003-10-07
Date Terminated2004-08-30

Reason for Recall

'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023049SYNCHRON LX I 725 CLINICAL SYSTEMBeckman Coulter, Inc. · 2002-10-04K014034MODIFICATION 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.

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