Recalls / —

—#25910

Product

Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.

FDA product code

JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K922823

Affected lot / code info

Not applicable.

Why it was recalled

Spring failure, design defect in component.

Root cause (FDA determination)

Other

Action the firm took

A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)

Recalling firm

Firm

Beckman Coulter Inc

Address

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

Distribution

Distribution pattern

Product has been distributed in US from 8/92 to present. All these units are affected.

Timeline

Recall initiated

2003-01-27

Posted by FDA

2003-03-06

Terminated

2003-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.