—#116876

Product

AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.

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: All Instrument Serial Numbers with Software Versions 4.11 and Prior 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 Model Numbers and Part Numbers listed above respecitively.

Why it was recalled

Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter sent an Urgent Product Correction letter during the week of March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed of the software limitation and provides instructions to be taken (temporary workaround) until the software is upgraded and released. Customer contact information provided: "Call Center Hotline at 800 854-3633. New customers will receive a copy of the customer notification at the time of installation by the Field Service Personnel until revised software that corrects this issue is released.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.

Timeline

Recall initiated: 2013-03-20
Posted by FDA: 2013-04-24
Terminated: 2014-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.