—#122247

Product

Access 2 Immunoassay System, Part Number: 81600N 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: K922823
Affected lot / code info: Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810

Why it was recalled

Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

A phone call was made on 9/12/13 to customer who received the Access 2 System. The phone script explains the problem identified of a possible wrong fuse and may result in failure of the fuse to operate properly. Customer was instructed that their Field Service Engineer, will call them back the following week to check on their system and replace the fuses if necessary. If you have any questions concerning this information, please call 952-393-8546.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.

Timeline

Recall initiated: 2013-09-12
Posted by FDA: 2013-11-14
Terminated: 2013-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.