—#118910

Product

AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K112412
Affected lot / code info: Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All

Why it was recalled

The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.

Root cause (FDA determination)

Software design

Action the firm took

An Urgent Product Correction letter dated 5/29/13 was sent on the week of June 3, 2013 to all the customers who received the AU5800 Clinical Chemistry Analyzer with Automation Ready (AR) Connection (All Software versions). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to complete and return the enclosed Response Form within 10 days and to share the information with their laboratory staff. Customers with questions are instructed to contact the 24 hours Call Center (Hotline) at (800) 854-3633 in the US and Canada.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.

Timeline

Recall initiated: 2013-06-03
Posted by FDA: 2013-07-31
Terminated: 2014-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.