Recalls / —

—#27444

Product

ACCESS Estradiol Reagent Test System

FDA product code

CHP — Radioimmunoassay, Estradiol

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K973743

Affected lot / code info

Lot number 215173

Why it was recalled

Short volume, resulting possibility of falsely elevated results.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-05-08

Posted by FDA

2003-05-29

Terminated

2003-10-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.