Recalls / —

—#26417

Product

ICON DS hCG, an in-vitro diagnostic. Part number 44025.

FDA product code

JHI — Visual, Pregnancy Hcg, Prescription Use

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K993203

Affected lot / code info

Lot numbers hCG010401, hCG010704, hCG010902

Why it was recalled

Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.

Root cause (FDA determination)

Other

Action the firm took

Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.

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

2003-02-20

Posted by FDA

2003-04-02

Terminated

2003-09-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26417. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.