—#48212

Product

UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer

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: 221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F (exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp 6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07), 221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F (exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp 6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07), 221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All software versions

Why it was recalled

The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action (PCA) letter was sent on July 28, 2006 to all Dxl customers to inform them that due to a recent change in packaging it is possible that the neck of the wash buffer cube can be extended higher than intended. This condition can cause the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. If they are running System software version 2.2.2 (distributed beginning March 2006) and greater it will detect the premature out-of-buffer state, thus preventing the potential for erroneous results. The letter also informed the customers that if they run system software version 2.2.1 or earlier with these wash buffer lot numbers, the premature out-of-buffer state will not be detected immediately, leading to the potential for erroneous results. They were informed that Installation of software version 2.2.2 or greater is mandatory. To ensure immediate upgrade to version 2.2.2, customers are to contact the Clinical Support Center or their local Beckman Coulter representative. After system software version 2.2.2 or greater is installed, the system will detect the out-of-buffer state, stop sample processing, and suppress results. One of the following Event Log messages will be posted: ''Air or excessive restriction has compromised wash buffer delivery'' or ''Air detected in the wash buffer supply line'' To prevent out-of-buffer events users are to complete the enclosed procedure: Calibrating the Wash Buffet Level Sensor. Completing the enclosed procedure before using any of the affected lots of Part Number 8547197 will eliminate unnecessary workflow interruptions. Customers are to share the information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. They are also instructed to complete and return the enclosed response form within 10 days so that the firm can be assured they were notified.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Worldwide distribution --- including USA and country of Canada.

Timeline

Recall initiated: 2006-07-28
Posted by FDA: 2006-09-23
Terminated: 2012-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.