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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers

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 Class 2 Device Recall Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzerssee related information
Date Initiated by FirmFebruary 13, 2017
Date PostedApril 03, 2017
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-1704-2017
Recall Event ID 76486
510(K)NumberK112412 K961274 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductBeckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are 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 ion selective electrode.
Code Information Not applicable
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
FDA Determined
Cause 2		Process control
ActionBeckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support Center: http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada; Outside the United States and Canada, contact their Beckman Coulter representative.
Quantity in Commerce2 sheets (20 labels/sheet)
DistributionUS Distribution : MA ., Internationally to Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
510(K)s with Product Code = JJE
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