Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
FDA Recall Z-1873-2013 · Posted 2013-08-02
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-10-26
Date Terminated2013-10-18
Product Quantity338 units (11 units in the US)
Reason for Recall
Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
Firm Action
A recall notification letter was forwarded to all their customers on 11/1/12 who purchased the AU5800 Clinical Chemistry Analyzer. The customers were informed of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Reponse form within 10 days. Customers with questions are instructed to call (800) 854-3633 or contact their local BCI Representative.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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