Recalls / —

—#29990

Product

Coulter DNA Prep Reagents Kit Part 6607055

FDA product code

MAQ — Kit, Dna Detection, Human Papillomavirus

Device class

Class 3

Medical specialty

Unknown

Affected lot / code info

Lot # 760203k-760208k, 760213k, 760218k

Why it was recalled

Labeling Error-Omission of 'Research Use Only'

Root cause (FDA determination)

Other

Action the firm took

All customers are to be notified with a product correction action letter.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-10-10

Posted by FDA

2003-11-19

Terminated

2004-03-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.