ClearanceBrief
Recall Z-1099-04 ยท MRR System, Test, Low Density, Lipoprotein

Beckman Coulter Inc

LDL Cholesterol Reagent (LDLD) Part No. 969706

DateJul 20, 2004 (initiated Feb 10, 2003)
StatusTerminated
ReasonExpiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
Root causeOther
Quantity291
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K014103SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
Beckman Coulter, Inc., Jan 28, 2002