ClearanceBrief
Recall Z-1155-04 ยท MRR System, Test, Low Density, Lipoprotein

Beckman Coulter Inc

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)

DateJul 23, 2004 (initiated Aug 15, 2003)
StatusTerminated
ReasonLDL Cholesterol component in controls are unstable.
Root causeOther
Quantity1780 all lots.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010748SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Beckman Coulter, Inc., Jul 10, 2001
K973696SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Beckman Instruments, Inc., Nov 24, 1997