Recalls / —

—#33130

Product

Array Systems Calibrator 5 Part No. 465250

FDA product code

GTQ — Antistreptolysin - Titer/Streptolysin O Reagent

Device class

Class 1

Medical specialty

Microbiology

510(k) numbers

K926236

Affected lot / code info

Lot M305283

Why it was recalled

The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

Root cause (FDA determination)

Other

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated

2003-12-17

Posted by FDA

2004-07-23

Terminated

2004-08-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33130. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.