Recalls / —

—#26128

Product

Access 2 Immunoassay System

510(k) numbers

K922823

Affected lot / code info

All fielded instruments.

Why it was recalled

False results from secondary pour off tubes

Root cause (FDA determination)

Other

Action the firm took

Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.

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

2003-01-30

Posted by FDA

2003-03-29

Terminated

2004-06-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26128. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.