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Terminated

Synchron LX Clinical Systems, Operating Software, All versions.

FDA Recall Z-1098-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeEXEMP
Date Initiated2003-10-10
Date Terminated2004-07-16
Product Quantity816

Reason for Recall

Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.

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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