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Terminated

Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.: 465421 Lot M301121 (level 1) part No.: 465422 Lot M301122 (level 2) Part No.: 465424 Lot M301124 (level 4)

FDA Recall Z-1155-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeMRR
Date Initiated2003-08-15
Date Terminated2004-08-30
Product Quantity1780 all lots.

Reason for Recall

LDL Cholesterol component in controls are unstable.

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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