Recalls / —

—#28266

Product

Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

FDA product code

KLS — Enzyme Immunoassay, Theophylline

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K922823

Affected lot / code info

Software version 3.29

Why it was recalled

Defective software media distributed with upgrade software may cause installation failure and systems lock.

Root cause (FDA determination)

Other

Action the firm took

Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.

Recalling firm

Firm

Beckman Coulter Inc

Address

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

Distribution

Distribution pattern

United States only, nationwide.

Timeline

Recall initiated

2003-06-18

Posted by FDA

2003-08-21

Terminated

2004-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28266. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.