—#124323

Product

UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764
Affected lot / code info: Part Number A30260. Serial Numbers 900781.

Why it was recalled

The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.

Timeline

Recall initiated: 2013-11-26
Posted by FDA: 2014-02-16
Terminated: 2014-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.