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Terminated

Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

FDA Recall Z-1156-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeMSS
Date Initiated2003-08-18
Date Terminated2004-08-30
Product Quantity5275

Reason for Recall

Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010748SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENTBeckman Coulter, Inc. · 2001-07-10K973696SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENTBeckman Instruments, Inc. · 1997-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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