ClearanceBrief
Recall Z-1152-04 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent

Beckman Coulter Inc

Array Systems Calibrator 5 Part No. 465250

DateJul 23, 2004 (initiated Dec 17, 2003)
StatusTerminated
ReasonThe ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
Root causeOther
Quantity1000
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K926236BECKMAN ANTI-STREPTOLYSIN O KIT
Beckman Instruments, Inc., Jun 15, 1993