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Terminated

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 Recall Z-1167-2013 · Posted 2013-04-24

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2013-03-20
Date Terminated2014-09-16
Product Quantity490

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112412AU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc. · 2011-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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