ClearanceBrief
Recall Z-0872-03 ยท CHP Radioimmunoassay, Estradiol

Beckman Coulter Inc

ACCESS Estradiol Reagent Test System

DateMay 29, 2003 (initiated May 8, 2003)
StatusTerminated
ReasonShort volume, resulting possibility of falsely elevated results.
Root causeOther
ActionConsignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
Quantity1593 kits
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Beckman Instruments, Inc., Oct 31, 1997